Date of Official Journal: 24.12.2011 Issue of Official Journal: 28152

REGULATION ON VETERINARY MEDICINAL PRODUCTS

CHAPTER ONE

Purpose, Scope, Legal Basis and Definitions

Purpose

ARTICLE 1 - (1) The purpose of this Regulation is to determine and to set out the practices

for manufacturing, importation, exportation, use, packaging, labeling, promotion,

transportation, storage and sales with or without prescriptions, marketing control and supply

of veterinary medical products.

Scope

ARTICLE 2 –(1) This Regulation shall apply to veterinary products that are prepared

industrially or employing industrial methods for placing on the market, veterinary medicated

premixes produced for use in medicated feeding stuffs, active substance used as starting

materials and substances having anabolic, anti-infectious, anti-parasitic, anti-inflammatory,

hormonal or psychotropic properties.

(2) When identifying a product as a veterinary medical product, the provisions of this

Regulation shall apply, if anything suspicious has occurred in respect of properties or this

definition conflicts with another definition provided in any other legislation.

(3) This Regulation shall not cover the following products:

a) Medicated feeding stuffs prepared using veterinary medicated premixes,

b) Veterinary medical products based on radioactive isotopes,

c) Additives incorporated into animal feeding stuffs,

ç) Products prepared in a pharmacy according to the prescription of a veterinary, commonly

known as a magistral formula, for a particular or group of animals or according to an official

formula and criteria laid down in an applicable pharmacopoeia for direct delivery to the end

user, notwithstanding the conditions applicable to availability, prescription and

administration,

d) products intended for use in line with research and development objectives, provided that

all regulations concerning human, animal and environmental health are exactly observed,

e)(Abrogated:OJ-20/12/2014-29211)

(4)(Abrogated:OJ-20/12/2014-29211)

Legal Basis

ARTICLE 3 –(1) This Regulation has been drawn up,

a) (Amended:OJ-11/1/2013-28525)(1) In reference to Sections 3, 4, 12, 13, 14, 31, 32, 34, 36,

37, 43 and 47 of the Law on Veterinary Services, Plant Health, Feed and Feeding Stuffs Law,

numbered 5996, dated 11/6/2010; and the Clauses 6, 7, 27 and 28 of the Decree-Law

Governing the Organization and Duties of the Ministry of Food, Agriculture and Livestock,

numbered 639, dated 3/6/2011; and Section 5 of the Law on Professional Veterinary Conduct,

Manner of Establishment and Authorized Duty-Frames of the Turkish Union of Veterinary

Surgeons and their Chambers, numbered 6343, dated 9/3/1954; and Section 4 of the Law for

the Preparation and Implementation of Technical Legislation governing Products, numbered

4703, dated 29/6/2001, and

b) By way of derogation from Directive 2001/82/EC of the European Parliament and of the

Council on Veterinary Medical Products, Directive 2004/28/EC of the European Parliament

and of the Council amending Directive 2001/82/EC on the Community code relating to

veterinary medical products, Commission Directive 2009/9/EC amending Directive

2001/82/EC of the European Parliament and of the Council on the Community code relating

to medical products for veterinary use, and the Commission Directive 91/412 laying down the

principles and guidelines for good manufacturing practice for veterinary medical products.

.

Definitions

ARTICLE 4 –(1) The following abbreviations and terms mentioned herein shall have the

following meanings;

a) Ministry: shall mean the Ministry of Food, Agriculture and Livestock;

b) Starting materials: shall mean any substance or material used for the manufacture of a

product, other than packaging materials;

c) (Amended:OJ-20/12/2014-29211) Bulk product: shall mean any liquid, semi-solid, solid

powder or granular pharmaceutical products, which are carried inside the special carrying

containers with large volume in order to be used at the further process steps or to be put into

the primary packaging,

ç) Outer packaging: shall mean the packaging into which the immediate packaging is placed;

d) Institute Directorate: shall mean either, or, where used in plural form, all of the Veterinary

Control Central Research Institute, other Veterinary Control Institute Directorates and the

Food and Mouth Diseases Institute Directorate;

e) Off-label use: shall mean the use of a veterinary medical product that is not in accordance

with the summary of the product characteristics as included in the packaging leaflet or label

thereof;

f) Label/Labeling: shall mean any written information supplied in printed form on both the

immediate and outer packaging of a product, as required by the related Ministry, about the

product;

g) Active substance: shall mean any pharmaceutical active substance used for preventing

animals from diseases, treating or modifying physiological functions of animals in a desired

way and/or fixing organic and functional disorders in animal organisms or diagnosing a

disease;

ğ) Pharmacovigilance: shall mean efforts pursued for the determination, assessment,

identification and prevention of adverse reactions and other potential problems associated

with products or use thereof;

h) Directorate General: shall mean the Directorate General of Food and Control;

ı) Immediate packaging: shall mean the container coming in direct contact with the

pharmaceutical form or containing the agents and excipients that collectively constitute the

pharmaceutical form of a product;

i) Provincial Directorate: shall mean the Provincial Directorate of Food, Agriculture and

Livestock;

j) District Directorate: shall mean the District Directorate of Food, Agriculture and Livestock;

k) (Amended:OJ-20/12/2014-29211) Adverse effect: shall mean the hazardous effects or

adverse events that are observed in animals, humans or the environment, as a result of use of a

product improperly and not in accordance with the product labeling and leaflets;

l) (Abrogated:OJ-20/12/2014-29211)

m) Generic medical product: shall mean a product that has the same qualitative and

quantitative composition, in terms of agents, same pharmaceutical form with the reference

product, the bio-equivalence of which is proven by bio-availability tests;

n) Withdrawal period: shall mean the period necessary between the last administration of the

veterinary medical product to animals, under normal conditions of use and in accordance

with the provisions of this Regulation, and the production of foodstuffs from such animals, in

order to protect public health by ensuring that such foodstuffs do not contain residues in

quantities in excess of the maximum residue limits for active substances laid down pursuant

to applicable laws;

o) Law: shall mean the Law on Veterinary Services, Plant Health, Food and Feeding Stuffs,

numbered 5996;

ö) Micro-organism culture: shall purport a population which is reproduced from a certain

bacteria, mushroom, virus or protozoa species and consisted of these living organisms;

p) Auto-vaccine: shall mean any vaccine prepared from cultures of micro-organisms isolated

from an animal to be administered to the same or other animals sharing the same environment

with the animal from which it is isolated;

r) Marketing authorization holder: shall mean any natural person or legal entity, public agency

or organization, that is in possession of authority to manufacture, import or export and place

the products in the market;

s) Marketing authorization manager: shall mean any person designated and delegated by the

marketing authorization holding natural persons or legal entities, public agencies and

organizations in relation to their products;

ş) Marketing authorization: shall purport the certificate drawn by the Ministry for enabling the

manufacture, importation, introduction to the market, storage and administration of a product

according to the product requirements as adopted and imposed by the Ministry;

t) Periodical safety update reports: shall mean the set of reports that contain safety

information obtained in the field as regards the product and have to be notified at regular time

intervals designated by the Ministry;

u) Package leaflet: shall mean the leaflet containing information for the user that accompanies

the medical product or is inserted into the packaging thereof;

ü) Prescription: shall mean the document, laid down in writing and properly dated and

undersigned by a veterinarian to the attention of a pharmacist who is authorized to sell

veterinary medical products or of another veterinarian, which includes the personal

identification data and residence information as well as degree or diploma number of the

issuing veterinarian, as well as information regarding the animal and its location, in addition

to recommended areas of application and administrative dosages and methods of use;

v) Reference medical product: shall mean any product duly licensed for introduction to the

market or authorized for marketing for the first time in the world, upon proofing of its

scientific acceptability, efficacy, quality and safety at required levels, for the aspects of active

substance(s);

y) Health-Care professional: shall mean any veterinarian, pharmacist or member of health-

care staff in assistance thereof;

z) Sales authorization: shall mean a document, issued by the Ministry, to render a product for

which marketing authorization has already been granted capable of being placed on the

market after it is manufactured or imported;

aa) Batch: shall mean a defined quantity of starting material, packaging material or product

processed in one process or series of processes so that it could be expected to be

homogeneous;

bb) Branch: shall mean a workplace founded upon written authorization of the Ministry to

pursue activities as a veterinary pharmaceutical warehouse, under the same trade name of the

original Ministry-licensed veterinary pharmaceutical warehouse but subject to liability and

instructions of another responsible manager;

cc)(Amended:OJ-11/1/2013-28525)(1) Representative pharmaceutical warehouse: shall mean

any veterinary pharmaceutical warehouse established in order to to store veterinary medical

products with marketing authorizations, and to perform such services as insertion of package

leaflets, labels/labeling, price tags and other similar ancillary packaging services;

çç) Diagnostic kit: shall mean the reagents containing such immunologic agents that are used

to diagnose or measure a disease or immunologic condition;

dd) Commercial name: shall mean the name given to the product;

ee) Manufacturing site: shall mean the location where the product is released for placing on

the market as ready for use;

ff) Product: shall mean the veterinary medical product,

gg) Veterinary Biological Product Surveillance Center: shall mean the functional or

departmental unit designated by the Ministry to carry out the surveillance checks and controls

applicable to authorizations granted for veterinary biological products;

ğğ) Veterinary biological product: shall purport to products such as vaccines, serums and etc.,

prepared for creating active or passive immunity, measuring the state of immunity or

diagnosing a disease or health disorder in animals;

hh) Veterinary pharmaceutical warehouse or warehouse: shall mean pharmaceutical

warehouses which pursue activities related with wholesale dealing in veterinary medical

products exclusively, under direct responsibility of a licensed pharmacist or veterinary

surgeon;

ıı) Homoeopathic veterinary medical product: shall mean any veterinary medical product

prepared from substances called homoeopathic stocks in accordance with a homoeopathic

manufacturing procedure described by the European Pharmacopoeia or, in the absence

thereof, by the pharmacopoeias currently used officially in the country;

ii) Premix for medicated feeding stuffs: shall mean any veterinary medical product prepared

in advance with a view to the subsequent manufacture of medicated feeding stuffs;

jj) Veterinary medical product surveillance center: shall mean the functional or departmental

unit designated by the Ministry to carry out the surveillance checks and controls applicable to

authorizations granted for veterinary biological products or within the framework of regular

scheduled checks and controls;

kk) Veterinary medical product: shall mean the products and veterinary biological products

which contain active substances made ready for use after passing through all production

stages, for use in or administration to animals;

ll) Excipient: shall mean the substances used for preserving active substances in the desired

pharmaceutical form and for desired periods, as well as enabling their safe and effective use

and in creation of the product’s pharmaceutical form;

nm) Assisting health-care services staff: shall mean any animal health-care technicians,

veterinary health-care technicians or laboratory assistant whose main duty is to be of help to

the veterinarian in time of, as well as carrying out sundries for accomplishment of procedures

during the delivery of animal health service;

nn) (Amended:OJ-20/12/2014-29211) Competent pharmacovigilance service institution:

shall mean the institution/organization, which has been authorized by the Ministry and which

has been established in order to provide service for pharmacovigilance activities;

oo) (Insertion:OJ-20/12/2014-29211) Competent pharmacovigilance manager: shall mean

the personnel, who carries out the pharmacovigilance works within the organization of the

pharmacovigilance service institution which has been authorized by the Ministry.

CHAPTER TWO

Marketing Authorization

General requirements

ARTICLE 5 – (1) No veterinary medical product may be placed on the market, warehoused

or administered in any form or manner whatsoever, unless a marketing authorization has been

issued by competent authorities in accordance with the second paragraph of Section 12 of the

Law and the provisions hereof.

(2) When a veterinary medical product has been granted an initial authorization in accordance

with the first paragraph, any additional species, strengths, pharmaceutical forms,

administration routes, presentations, as well as any variations and extensions, shall also be

granted an authorization by the Ministry in accordance with the first paragraph or be included

in the initial marketing authorization.

(3) The marketing authorization holder shall be responsible for the marketing of the medical

product. The designation of a representative shall not relieve the marketing authorization

holder of his legal responsibility.

(4) A veterinary medical product intended for use in food-producing animals may not conflict

with applicable laws on residue limits of veterinary medical products in foodstuffs of animal

origin. (Insertion:OJ-11/1/2013-28525) Authorizations of any products, which become on

contrary due to any amendments/changes to the legislation, shall be subjected to a re-

assessment within sixty days as of the date of any such amendment/change to the legislation.

(5) (Amended:OJ-11/1/2013-28525)(1) The Ministry may grant temporary authorizations for

importation or manufacturing at the location, for which a manufacturing authorization has

been granted by the Ministry, of the products or product starting materials which do not have

any marketing authorization as described below. In such case, there shall be no product, for

which a marketing authorization has been granted in Turkey, in replacement of the product for

use. However, the requirement for non-availability of any product, for which a marketing

authorization has been granted in Turkey, may not be sought for any products donated within

the best knowledge of the Ministry. (Amended sentence:OJ-20/12/2014-29211) Such

products, for which any temporary authorizations have been granted, may not be subject to

trading.

a) Products or starting materials necessary for identification of efficacy, safety and

pharmaceutical quality aspects of products pending an initial marketing authorization.

b) (Amended:OJ-20/12/2014-29211) Products or starting materials intended for use in

research and development activities to be conducted at universities and such other public

entities and organizations.

c) Products or starting materials intended for use on any animals at any protection areas or

rehabilitation centers belonging to any public organizations and institutions, universities,

foundations and associations carrying out activities in relation to any animal species in danger

of extinction, or in relation to wildlife.

ç) Products or starting materials donated from abroad to be used at animal shelters and

treatment and care locations belonging to municipalities, associations and foundations.

d) Products or starting materials intended for use in research and diagnostic activities to be

conducted at laboratories or veterinary faculties approved by the Ministry.

e) Products or starting materials intended to be used on the animals, corresponding to the

activities specified in the first paragraph of section 10 of the Law, or at any activities in

relation to protection, recovery or development of any gene resources by any real or legal

persons.

f) Products or starting materials intended to be used due to any of the reasons specified in the

sixth paragraph of section 12 of the Law.

g) Products or starting materials intended to be used on any animals brought from abroad for

any activities such as circus, fairs or racing purposes.

(6) (Amended:OJ-11/1/2013-28525)(1) In case of occurrence of any serious disease epidemic

threating animal life, where there is no authorized medical product for that condition in

existence or available to be used against such epidemic, or if the existing products are not

capable of fulfilling the need, then the Ministry may grant temporary authorization for use of

the below given products. (Abrogated sentence:OJ-20/12/2014-29211) (…)

a) Products authorized for use in another animal species or indication.

b) Products which can be manufactured at the manufacturing sites that are approved either by

the Ministry, or the Ministry of Heath, and the products which are authorized at the other

countries.

c) if there is no product as referred to in points (a) and (b), of a medical product authorized for

use in human beings in accordance with the applicable legislative acts relating to medical

products for human use.

(7) The provisions of paragraph six shall apply provided that the medical product, where

administered to food-producing animals, should contain active substances meeting the

requirements of legislative acts relating to residue limits of veterinary medical products in

foodstuffs of animal origin. Unless the medical product used indicates a withdrawal period for

the animal species concerned, the specified withdrawal period shall not be less than seven

days for eggs and milk, twenty-eight days in meat from poultry and mammals including fat

and offal, and five hundred degree-days in meat from fish. These periods may be increased by

the Ministry, in case of requirement. (Insertion:OJ-11/1/2013-28525)(1) However, in respect

of any homeopathic products and active substances, such period may be reduced to zero days,

provided that such products and substances are in conformity to the legislation regarding the

limits of residue at foodstuffs of animal origin.

(8) In the event that the products referred to in paragraph six above is used, then the Ministry

may take special precautionary measures, or ask the related parties to comply with certain

requirements with regard to importation, distribution, possession and use of the products.

(9) If an animal is being imported from, or exported to, a third country and is thereby subject

to specific binding health rules, then the Ministry may permit the use, for the animal in

question, of an immunological veterinary medical product that is not covered by a marketing

authorization in the country in question but is authorized under the legislation of the third

country. Special permission of the Directorate General should be sought and obtained, for

importation and use of immunologic medical products of the type concerned.

(10) (Amended:OJ-11/1/2013-28525)(1) The Ministry may, upon request, grant authorization

for exportation of the products exclusively for exportation purposes. In respect of

manufacturing and controlling of any products or bulk products manufactured for exportation

purposes, the request of the concerned buyer shall be taken into account. Such products may

not be used within the borders of the country. Controlling and responsibility for such products

shall be incumbent on the manufacturing site, the authorization holder, the buyer and the

country thereof.

(11) The Ministry may authorize importation or exportation of authorized products in bulk,

provided to the extent that this would not have any adverse effects on the efficacy, safety or

harmlessness of the product.

(12) (Amended:OJ-20/12/2014-29211) No additional marketing authorization shall be

granted to a product that has the identical formula and identical pharmaceutical form with

another product previously granted with marketing authorization in the name of the same

marketing authorization holder.

(13) No marketing authorization can be granted to different persons for products which are

proprietary to the same person staying on abroad and which contain identical active substance

in identical quantities, and have the same pharmaceutical form.

(14) The owner of a product, the marketing authorization of which has been revoked for

reasons specified under this Regulation, may not lodge any marketing authorization or

takeover applications for another product containing same active substance in same quantities,

and having same pharmaceutical form, unless after one year of such revocation.

(15) (Insertion:OJ-11/1/2013-28525)(1) (Amended:OJ-20/12/2014-29211) Inactivated auto-

vaccines, which are manufactured from antigens or pathogens obtained from the animals from

the same region for use in prevention or treatment at a farm at the same region, shall be

excluded from the scope of the marketing authorization.

(16) (Amended:OJ-20/12/2014-29211) The decision as to whether marketing authorization

would be obtained for any live auto-vaccines manufactured from antigens or pathogens

obtained from the animals available at the farms or poultry-houses at the same region for use

in treatment of a disease occurring in that region shall be made by the Directorate General.

Persons eligible for lodging marketing authorization applications

ARTICLE 6 – (1) The marketing authorization shall be granted to the natural and legal

persons described in the third paragraph of section 12 of the Law.

(2) Legal persons or public entities and organizations may obtain marketing authorization by

appointing one of the professionals specified in first paragraph of this Article as the marketing

authorization manager. The natural persons described in the third paragraph of section 12 of

the Law shall be deemed as marketing authorization managers.

(3) (Amended:OJ-20/12/2014-29211) In order for qualifying for pursuing activities in

marketing authorization covered by this Regulation, natural or legal persons shall obtain

certificates of authorization for engagement with veterinary medical products, from the

Ministry.

(4) The marketing authorization holders should obtain a sales authorization certificate, before

placing their products on the market.

Certificate of Authorization for Engagement

ARTICLE 7 – (1) Both natural and legal persons shall lodge applications with the

Directorate General, in order to obtain veterinary medical product engagement authorization

certificates, accompanied by the following information and documents;

a) (Amended:OJ-11/1/2013-28525)(1) A petition covering the Republic of Turkey ID

Number, and the declaration of residence, work telephone number and the fax number and the

e-mail address of the marketing authorization manager.

b) Where the applicant is a legal person, original copy of the labor contract of the related

professional, as approved by a notary public, which clearly states that he is employed as a

marketing authorization manager and in such capacity, will be in charge of activities falling

within the framework of related legislative acts,

c) In case of legal persons, a valid and up-to-date certificate obtained from related public

agency, indicating that the marketing authorization managers appointed for duty therein are

insured according to the effective laws, and currently working for such persons,

ç) (Amended:OJ-11/1/2013-28525)(1) An up-to-date and valid certificate of registration to

the professional chamber given by the professional chamber, to which the marketing

authorization manager is registered, and if there is no any such chamber for that profession,

then the copy of the diploma or certificate of graduation of such person, two passport

photographs and the circular of signature of the same,

d) If the applicant is a legal person, a commercial registry excerpt denoting the registered

address of the company, founding objectives, partnership structure and people in charge of

governance of the company, giving their respective duties, titles and signature authority

frames,

e) Information on the applicant’s product recall plan in order to recall products from the

market and people responsible for implementing the same,

f) (Amended:OJ-11/1/2013-28525)(1) Photocopies of the valid and up-to-date certificates

pertaining to the total quality management system, or the photocopy of the documents

describing the intra-company quality assurance systems, all covering any other matters,

deemed appropriate by the marketing authorization holder, as well as the documentation

regarding increase of customer and employee satisfaction, decrease of costs, creation of a

hight competitive power, prevention of errors, and establishment of the documentation,

records and archive as required by the relevant legislation, in respect of the activities of the

marketing authorization holder in relation to the veterinary medical products.

(2) If one of the owners or partners of the applicant in the form of a legal person has

appropriate degree of major and professional title in the area of concern, and is further

appointed to be the marketing authorization manager, then the labor contract as approved by a

notary public shall not be required.

(3) (Amended:OJ-11/1/2013-28525)(1) Holders of certificates shall be obliged to notify the

Ministry of any potential change in the information based on which, the engagement

authorization certificates are drawn, in no later than thirty days of such effect. Any finding or

determination of failure by the certificate holders to notify such changes within the specified

period of time or of any attempted or actual falsification or fraud will lead to immediate

suspension of the engagement authorization certificates of the holders, along with subsequent

discontinuation of their activities covered by the scope of this Regulation.

(4) The marketing authorization manager will have to notify the Ministry, of his resignation,

all in one month of his quitting office. If he fails to do so and this fact is ascertained, the

marketing authorization manager in default will not be permitted by the Ministry to assume

office as a manager in charge of veterinary medical products for two years to advance upon

his resignation or departure from office.

(5) Legal person certificate holders will have to lodge with the Directorate General, a valid

and up-to-date letter of the Social Security Institution, which demonstrates that their

respective marketing authorization managers continue to hold this position in January of each

year. Those certificate holders failing to make this notification shall be warned and given a

period of one month to comply. Those, who fail to make the notification sought within the

aforementioned time allowance, will have their certificates suspended, and their activities

covered by the scope of this Regulation shall be ceased.

Marketing authorization procedures

ARTICLE 8 – (1) (Amended paragraph:OJ-11/1/2013-28525)(1) The application shall be

submitted to the Directorate General, with a file covering the below given details and

documents. The application file shall be drawn up and prepared in accordance with the

applicable guidelines.

a) A valid copy of certificate of authorization for engagement,

b) name or business name and permanent address or registered place of business of the person

responsible for placing the veterinary medical product on the market and, if different, of the

manufacturer or manufacturers involved, and of the sites of manufacture,

c) name of the veterinary medical product,

ç) qualitative and quantitative particulars of all the constituents of the veterinary medical

product, using the usual terminology, and giving the international non-proprietary name

recommended by the World Health Organization, where such a name exists,

d) description of the method of manufacture,

e) therapeutic indications, contra-indications and adverse reactions,

f) dosage for the various species of animal for which the veterinary medical product is

intended to be used, its pharmaceutical form, method and route of administration and

proposed shelf life, and any pharmacovigilance details and precautions, if any,

g) explanations of the precautionary and safety measures to be taken when the product is

stored, when it is administered to animals and when waste therefrom is disposed of, together

with an indication of any potential risks the medical product might pose to the environment

and the health of humans, animals or plants,

h) indication of the withdrawal period and a tolerance level for residues which may be

accepted in foodstuffs without risk for the consumer, together with routine analysis methods

which could be used by the Directorate General to trace residues, to be proposed and justified

by the applicant,

ı) description of the control testing methods employed by the manufacturer,

i) results of following tests, as undersigned by people the technical and professional

qualifications of which are proven in data supplied on resumes and further proven

scientifically:

1) physico-chemical, biological or microbiological tests,

2) Safety and residues tests,

3) pre-clinical and clinical trials,

4) tests for assessment of environmental impacts.

j) a summary of the product characteristics, one or more specimens of the sales presentation

of the veterinary product together with the package insert,

k) (Amended:OJ-20/12/2014-29211) Certificate of Good Manufacturing Practice (GMP)

issued or accepted by the Ministry, for the manufacturing sites of the products,

l) (Amended:OJ-20/12/2014-29211) If the products are authorized abroad, a summary of the

product characteristics and/or proposed texts of package inserts/ product labeling, certificates

of free sale issued concerning the product, justification of reasons if the product is authorized

but not yet placed on the market and details of any decision to refuse authorization, in any

jurisdiction and the reasons for that decision,

m) (Amended:OJ-20/12/2014-29211) If substances of animal origin are employed for the

manufacture of a certain product, a certificate drawn to the effect that such ingredients are

totally appropriate in terms of any pathogens specified by the Ministry,

n) (Amended:OJ-20/12/2014-29211) If the products are authorized abroad, the list of

countries in which the product is placed on the market and letter of authorization issued by the

proprietor of the product seated on abroad, to demonstrate that the applicant is the sole

authorized agent for the product within the territory of Turkey, duly devised with exclusive

rights concerning importation of the product to Turkey, obtaining of marketing authorization

and placing the product on the market.

o) (Insertion:OJ-20/12/2014-29211) In case of contract manufacturing, the agreements

executed by and between the parties.

(2) (Amended:OJ-20/12/2014-29211) If the products are authorized abroad, certificates

specified in points (ç), (k) and (l) above should be approved by the competent authorities of

the relevant country responsible for marketing authorization and control of the products, with

signatures and seals affixed further verified by a Turkish consulate or diplomatic mission

operating in that country. If the aforementioned documents are approved by another person or

organization authorized by the competent authorities, then an official letter will be required

from such competent authorities, for verification of capacities of the approving person or

organization to do so. These documents shall be submitted along with their certified Turkish

translations.

(3) The Ministry may either bring new standards to or require observance of internationally

recognized standards in studies concerning the products or laboratories to host the same.

Studies concerning the Product

ARTICLE 9 – (1) (Amended:OJ-20/12/2014-29211) Provided that provisions of the

Decree/Law No. 551 of 24/6/1995 on Protection of Patented Rights are reserved, the applicant

shall not be required to provide the results of the safety and residue tests or of the pre-clinical

and clinical trials if he can demonstrate that the medical product is a generic of a reference

medical product. A generic veterinary medical product authorized pursuant to this provision

shall not be placed on the market until six years have elapsed from the initial authorization of

the reference product. However, the six-year period provided above shall be extended to nine

years in the case of veterinary medical products for fish or bees or other minor species. In the

case of veterinary medical products intended for one or more food-producing species, the six-

year period provided above shall be extended by one year for each extension of the marketing

authorization to another food-producing species, if it is authorized within the five years

following the granting of the initial marketing authorization. This period shall not, however,

exceed a total of nine years, for a marketing authorization for four or more food-producing

species.

(2) The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives

of an active substance shall be considered to be the same active substance, unless they differ

significantly in properties with regard to safety and/or efficacy. In such cases, additional

information intended to provide proof of the safety and/or efficacy of the various salts, esters

or derivatives of an authorized active substance must be supplied by the applicant. The

various immediate-release oral pharmaceutical forms shall be considered to be one and the

same pharmaceutical form. Bio-availability studies need not be required of the applicant if he

can demonstrate that the generic medical product meets the relevant criteria as defined in the

appropriate detailed guidelines.

(3) In cases where the veterinary medical product does not fall under the definition of a

generic medical product, or, where bio-equivalence cannot be demonstrated through bio-

availability studies or in the case of changes to the active substance(s), therapeutic indications,

strength, pharmaceutical form or route of administration vis-à-vis the reference medical

product, the results of the appropriate safety and residue tests and pre-clinical tests or clinical

trials shall be provided.

(4) Where a biological veterinary medical product which is similar to a reference biological

veterinary medical product does not meet the conditions in the definition of generic medical

products, owing to, in particular, differences relating to raw materials or in manufacturing

processes of the biological veterinary medical product and the reference biological veterinary

medical product, the results of appropriate pre-clinical tests or clinical trials relating to these

conditions must be provided. The type of supplementary data on and file for the veterinary

medical product to be provided must comply with the relevant criteria stated in the respective

guidelines and the related notes of detailed guidelines. The results of other tests and trials

from the reference medical product's dossier shall not be provided.

(5) (Amended:OJ-11/1/2013-28525)(1) With the exception of point (i) of the first paragraph

of Article 8 of this Regulation, results of safety and residue tests or of pre-clinical tests or

clinical trials may not be sought, if it is demonstrated that the active substance has been in

well-established veterinary use for ten years, with recognized efficacy and an acceptable level

of safety, as per the requirements specified in the product file, and by being supported by

appropriate scientific literature.

(6) If an applicant makes use of scientific literature to obtain authorization for a food-

producing species, and submits, in respect of the same medical product and with a view to

obtaining authorization for another food-producing species, new residue studies, together with

further clinical trials, it shall not be permissible for a third party to use such studies or such

trials, for a period of three years from the grant of the authorization for which they were

carried out.

(7) In the case of veterinary medical products containing active substances used in the

composition of authorized veterinary medical products but not hitherto used in combination

for therapeutic purposes, the results of safety and residue tests, if necessary, and new pre-

clinical tests or new clinical trials relating to that combination shall be provided. However, it

shall not be necessary to provide scientific references relating to each individual active

substance.

(8) After the marketing authorization has been granted, the marketing authorization holder

may allow use to be made of the pharmaceutical, safety and residues, pre-clinical and clinical

documentation contained in the file for the veterinary medical product with a view to

examining a subsequent application for a veterinary medical product having the same

qualitative and quantitative composition in active substances and the same pharmaceutical

form.

(9) By way of derogation from point (i) of the first sub-paragraph of Article 8, and in

exceptional circumstances with respect to immunological veterinary medical products, the

Ministry may not require the applicant to provide the results of certain field trials on the target

species if these trials cannot be carried out for duly substantiated reasons.

(10) (Amended:OJ-11/1/2013-28525)(1) The Ministry may not request some of the

requirements, information and documents, which are demanded for the other products, during

granting of a marketing authorization for the products to be used for aquarium fish, cage

birds, homing pigeons, terrarium animals, small rodents, and ferrets and rabbits kept

exclusively as pets.

(11) (Insertion:OJ-11/1/2013-28525)(1) Provided that the other provisions of this Regulation,

and the provisions of the regulations regarding the residue limits of foodstuff of animal origin

are reserved; the Ministry may implement a dedicated and simplified authorization process

only for the homeopatchic veterinary medical products which meet all of the below listed

requirements;

a) The administration method of which is available in the European Pharmacopeia or in any

other official pharmacopeia used at any other country,

b) Any products which do not have any therapeutic indication specified on its veterinary

medical product label or at any other information source,

c) Any products, for which a dilution degree sufficient for guaranteeing safety of the product,

in particular those which are not denser than 1/10.000 as per the main tenture.

(12) (Insertion:OJ-11/1/2013-28525)(1) In respect of any homeopathic products, for which it

is claimed that there is a therapeutic indication, or which do not correspond to the products

described in the eleventh paragraph; the ordinary authorization procedure shall be applied.

The Ministry may not seek some of the information, documents and studies, demanded for the

other products, for any homeopathic products, which could not be included to the dedicated

simplified authorization procedure, or which will be used for pets or exotic species, and may

bring out some special requirements thereto. Dedicated simplified authorization procedure

may be implemented for various homeopathic veterinary products derived from the same

homeopathic stock or stocks. The below listed details shall be provided regarding the product

with the purpose of ensuring the pharmaceutical quality of the products, and ensuring that

each batch has the same homogeneity;

a) Names of the homeopathic stock or stocks, either scientific or specified in the

pharmacopeia; details about any probable administration routes of the same; and the

pharmaceutical form and dilution rate of the same.

b) Detailed information about how the homeopathic stock or stocks is/are obtained and

controlled, evidence about the homeopathic nature, and how it is ensured that there is no

pathogens in the homeopathic products containing biologicals.

c) Manufacturing and controlling protocol and dilution and potantiation description for each

pharmaceutical form.

ç) Manufacturing authorization for the relevant medical product.

d) The certified copies of any licenses or authorizations granted by any other country for the

same medical product.

e) One or more samples of immediate and/or outer package, mock-ups of the product.

f) Data regarding the stability of the product.

g) The suggested/proposed withdrawal period along with all necessary verification.

Summary of product characteristics

ARTICLE 10 – (1) The summary of the product characteristics shall contain, in the order

indicated below, the following information;

a) name of the veterinary medical product followed by the strength and the pharmaceutical

form;

b) qualitative and quantitative composition in terms of the active substances and constituents

of the excipient, knowledge of which is essential for proper administration of the medical

product. The usual common name or chemical description shall be used;

c) pharmaceutical form;

ç) clinical particulars;

1) target species,

2) indications for use, specifying the target species,

3) contra-indications,

4) special warnings for each target species,

5) special precautions for use, including special precautions to be taken by the person

administering the medical product to the animals;

6) adverse reactions (frequency and seriousness),

7) use during pregnancy, lactation or lay,

8) interaction with other medical products and other forms of interaction,

9) amounts to be administered (dosages) and administration route,

10) overdose (symptoms, emergency procedures, antidotes), if necessary,

11) withdrawal periods for the various foodstuffs, including those for which the withdrawal

period is zero;

d) pharmacological properties:

1) pharmacodynamic properties,

2) pharmacokinetic particulars;

e) pharmaceutical particulars:

1) list of composition,

2) major/important incompatibilities,

3) shelf life, when necessary after reconstitution of the medical product or when the

immediate packaging is opened for the first time,

4) special precautions for storage,

5) nature and composition of immediate packaging,

6) special precautions for the disposal of unused veterinary medical products or waste

materials derived from the use of such products, if appropriate;

f) Names and addresses of the marketing authorization holder and the manufacturer,

g) first, subsequent revision and renewal dates of marketing authorization,

ğ) Restrictions on sale/release/use of the medical product to be added.

(2) Applicants shall ensure that the detailed and critical summaries referred to in the (i) sub-

paragraph of Article 8(1) are drafted and signed by persons with the requisite technical or

professional qualifications, set out in a brief curriculum vitae, before being submitted to the

competent authorities. Persons with the technical or professional qualifications referred to

above shall justify any use made of the scientific literature in accordance with the file relating

to the veterinary medical product. A detailed curriculum vitae of the persons referred to above

shall be appended to the detailed critical summaries.

Label/Labeling and Package Leaflets

ARTICLE 11 – (1) (Amended:OJ-20/12/2014-29211) All veterinary medical products

granted with a marketing authorization should be presented to the market together with a

Ministry approved package leaflet and label. However, this requirement may be ignored by

the Ministry for products with each package of which package leaflet may not physically be

provided.

(2) (Amended:OJ-20/12/2014-29211) No modifications can be made in any approved

package leaflet and labeling, unless with consent of the Ministry.

(3) Products not complying with the requirements covered in this Article shall be deemed as

faulty.

(4) The immediate packaging and outer packaging of veterinary medical products shall bear

the following information, which shall conform with the summary of product characteristics,

and shall appear in legible characters:

a) the words “For Animal Treatment Only”,

b) the name of the medical product, followed by its strength and pharmaceutical form,

c) qualitative and quantitative composition of the veterinary medical product, expressed in

active ingredients per dose-unit or as a percentage, according to the pharmaceutical form,

ç) If required, statement of names and quantities of excipients,

d) Purpose of Use in brief or treatment class,

e) the species of animal for which the veterinary medical product is intended, the method and,

if necessary, the route of administration,

f) if necessary, symptoms of intoxication and antidote,

g) brief warning on times needed to elapse for veterinary medical products that are authorized

for use in foodstuffs, to lower down to maximum permissible residue levels depending on the

types of foodstuffs,

ğ) warnings, “Read the leaflet before use” and “Keep out of reach of children”,

h) Storage conditions and if desired, symptoms of deformation,

ı) If required, information on how to dispose the packaging or leftovers thereof, at the end of

use,

i) form of commercial presentation,

j) Location and terms of sale,

k) Marketing authorization date and number,

l) Name and address of marketing authorization holder,

m) name and address of the manufacturing site,

n) If required, the license owner,

o) If required, symbol or figure relating to the animal species,

ö) Batch number,

p) (Amended:OJ-20/12/2014-29211) Expiry date and/or date of manufacture,

(5) If the above mentioned information cannot fit in the space provided for their placement as

a whole or it becomes necessary to use typeface in too small points that makes reading

difficult, certain paragraphs/sections that are deemed ignorable for health may be removed

from labeling, provided that such removal is authorized by the Ministry.

(6) For such small packages as ampoules or small containers on which it is impossible to give

the particulars above, inclusion of the following information shall be deemed sufficient, save,

however, that the immediate packaging is presented within an outer packaging and the

product is delivered with a leaflet:

a) Name and strength of the veterinary medical product,

b) Active ingredients expressed quantitatively,

c) Route of administration,

ç) Batch number,

d) Expiry date,

e) the words “For Animal Treatment Only”

(7) (Amended:OJ-20/12/2014-29211) All information shall be presented in Turkish. Upon

request, the Ministry may authorize sales of products with multilingual leaflets or labeling,

containing text in Turkish. Any technical details available in the multilingual labeling are

required to be consistent the Turkish labeling details. For products authorized abroad,

veterinary medical products may be placed on the market with Turkish versions of their

labeling juxtaposed over those prepared in the original language of the exporting country and

with leaflets authorized abroad and prepared in Turkish. In the event that the practice of

Turkish interior labeling will have negative impacts on the product, then the Ministry may

authorize that details of interior labeling are not in Turkish, provided that the product is

provided along with a Turkish outer packaging and/or leaflet.

(8) Where no outer packaging is provided, all information contained in the leaflet should be

shown on the container (i.e. bottle) and if this is not practically possible, appropriate measures

be taken to ensure that a package insert is delivered with every shipment of a veterinary

medical product.

(9) The leaflets shall at least include the following information, in accordance with the file

relating to and characteristics of authorized veterinary medical product:

a) the words “For Animal Treatment Only”,

b) name of the veterinary medical product and its strength, and a term describing the animal

species in which it is intended for use or the word “veterinary”,

c) Pharmaceutical form,

ç) Therapeutic effect,

d) Composition

e) pharmaceutical particulars:

f) Area of application, indications of use, time, interval, dosing rates and target animal

species,

g) Specific technical data and special precautions for target species,

ğ) Undesirable effects,

h) Interaction with other medicaments and other forms of interaction (i.e. compatibility and

incompatibility etc.)

ı) Overdose (symptoms, emergency procedures, antidotes),

i) times needed to elapse and other precautions to be taken for veterinary medical products

that are authorized for use in foodstuffs, to lower down to maximum permissible residue

levels depending on the types of foodstuffs,

j) contra-indications,

k) common warnings such as “Consult a veterinarian before use”, “Keep out of reach of

children” , and “Consult a veterinarian upon an unexpected effect.”

l) Special precautions to be taken by the person administering the medical product,

m) Special precautions for storage and shelf life,

n) Special precautions for the disposal of unused medical product or waste material and on

non-target species,

o) Sales presentation form showing the packaging qualitatively and quantitatively,

ö) Location and terms of sale,

p) Date on which the leaflet is approved,

r) Marketing authorization date and number,

s) Name and address of the marketing authorization holder

ş) Manufacturer’s name and address.

(10) The leaflets and labeling of homeopathic veterinary medical products may only include

the following information:

a) the words “homeopathic medical product for veterinary use”, in clearly legible form,

b) the scientific name of the stock or stocks followed by the degree of dilution, using the

symbols of the pharmacopoeia taken as reference in manufacture of the medical product,

c) name and address of the marketing authorization holder and, where appropriate, of the

manufacturer,

ç) method of administration and, if necessary, route,

d) Expiry date,

e) Pharmaceutical form,

f) contents of the sales presentation,

g) special storage precautions, if any,

ğ) target species,

h) a special warning if necessary for the medical product.

ı) Batch number,

i) Marketing authorization date and registration number,

(11) The Ministry may require that information which are essential and based on data

obtained at a later time and symbols for the tracking system be included in package leaflets

and labeling, in addition to the information described above. This also applies to previously

approved package leaflets and labeling.

(12) No photographic imagery or pictures may be included in labeling and leaflets. However,

medical products for veterinary use in non-food-producing animals and with special methods

of administration may be excluded. Besides the corporate emblem or logo, labeling may

include animal figures indicating the species in which the medical product can be used. The

Ministry may render inclusion of certain symbols or figures in the leaflet or labeling,

mandatory.

Prescriptions

ARTICLE 12 – (1) For the purpose of enforcement of this Regulation, veterinary medical

products are divided into to categories as those available with and without prescription.

(2) Those products that bear the following characteristics will be available with prescription:

a) those products subject to official restrictions on supply or use,

b) those products which have narrow safety ranges and may pose threats against human,

animal and environmental health, even if used in accordance with the information supplied on

labels,

c) those products which are used in or administered to food-producing animals and

particularly cause residues,

ç) Those products the preparation of which is ordered by veterinarians from pharmacists,

d) Those products which are suitable for use beyond their intended use, due to their

properties,

e) Those products which require or cause major modifications that may effect the diagnosis or

treatment,

f) Those products, the active substances of which are placed on the market for a period less

than five years.

(3) Save provisions of the second paragraph above are reserved, the Ministry may grant

authorization for the sales without prescription of veterinary medical products that are

appraised to be free of any potential health-related risks, eligible for routine use and not

abusable, after a thorough assessment of the various aspects of the product such as the

quantities of active substances in each unit, route of administration and toxicological effects.

Naming for purposes of Trade

ARTICLE 13 – (1) The following requirements shall duly be taken into consideration, when

assigning names to veterinary medical products, for trading purposes:

a) Names may not contain misleading statements about product characteristics.

b) (Amended:OJ-20/12/2014-29211) Disease names, pathogens and symptoms thereof may

not be used in place or as part of trade names. For the biological products; strain, serotype or

disease names as well as abbreviations thereof may be used.

c) Active substances contained in the product may not be used as a stand-alone trade name.

However, the names of active substances may be assigned as the trade name of the products

containing them, accompanied by the trade name or business title of the marketing

authorization holder.

ç) (Amended:OJ-20/12/2014-29211) A trade name originally given to an already authorized

medical product or to a product the marketing authorization of which has been revoked may

not be used in any other medical product, except those of the marketing authorization holder

which bear the same name but have different pharmaceutical form and priorly granted with an

authorization. However, those medical products the marketing authorizations of which have

been revoked on consent or request of the authorization holders, and which have not yet been

placed on the market are excluded.

d) The proposed trade name of the medical product for veterinary use shall be assessed by the

Ministry. The Ministry may require a change in the names as proposed, in cases of necessity.

e) Provided that compliance with the provisions hereof is sustained, trade names proposed by

the marketing authorization holder may be accepted. However, the registered intellectual

property rights attached to names obtained from competent authorities and Ministry’s right to

action for avoidance of doubt between the names of other products are hereby reserved.

(2) The Ministry may require the modification or replacement of a particular or group of

names or expressions indicative of the strengths of authorized veterinary medical products,

which are not consistent with the requirements laid down herein. No charges or fees shall be

applicable to procedures relating to modifications and replacements of names as required by

the Ministry.

Pre-investigation of application files

ARTICLE 14 – (1) The files submitted by applicants for obtaining marketing authorization

for their medical products for veterinary use shall first be assessed by the Directorate General

for order and integrity of their administrative content, through a pre-investigation.

(2) The pre-investigation shall be concluded in no later than thirty days of first receipt of the

application dossier by the Ministry. Those dossiers found qualifying and eligible at the end of

this pre-investigation will further be submitted to the Committee for evaluation.

(3) In the event of defects or inconsistencies found in an application dossier, the applicant

shall immediately be informed on the situation through a notice in writing given to the same

in no later than fifteen days of completion of pre-investigation. The applicant will then supply

the missing information and/or make good inconsistencies so discovered, all within ninety

days. If he fails to make up and complete the information and documents he is expected to

furnish within such period of time, the applicant will have his application dossier returned.

(4) Once the defects and inconsistencies found during the pre-investigation stage are totally

eliminated and the files submitted to the Directorate General as complete, the pre-

investigation will be finalised in thirty days. Those dossiers found qualifying and eligible will

be submitted to the Committee for evaluation. In case of defects or inconsistencies found in

an application dossier at this stage, it will be returned to its original owner, without further

process.

Examination of Application Dossiers

ARTICLE 15 – (1) The application dossiers verified and approved for integrity and order of

administrative content as a result of the pre-investigations held at the Directorate General

shall be further processed and finalised all within two hundred and ten days upon written

notification of the applicants of the fact that they are being submitted to the committee. This

period is exclusive of the extra time granted to the applicant during the pre-investigation

stage, time consumed to performance of analyses on products and time required for obtaining

opinions from other entities and organizations.

(2) During the procedure for marketing authorization, the Ministry:-

a) shall check that the documentation submitted in support of the application complies with

the requirements laid down in above and, on the basis of the reports drawn up by the experts,

ascertain whether the conditions for the issue of the marketing authorization have been

fulfilled;

b) may submit the medical product, its raw materials and if necessary intermediate products or

other constituent materials for testing by a State laboratory or by a laboratory designated for

that purpose, in order to ensure that the testing methods employed by the manufacturer and

described in the application documents, in accordance with point (i) of the first paragraph of

Article 8, are satisfactory.

c) shall check appropriateness of analytical detection method proposed by the applicant for

establishment of residues by entering in a comprehensive exchange of information with

related organizations.

(3) The Ministry may, where appropriate, require further information. In this case, the time-

limit of two hundred and ten days shall be suspended. Likewise, if the applicant is required to

provide verbal or written clarifications, this time-limit shall be suspended until the further

data required have been provided.

(4) The Ministry may perform audits at premises where the testing and controls have been

performed, with a view to ensure that exported veterinary medical products are manufactured

and/or their control testing is performed in compliance with this Regulation.

(5) At the end of the audits mentioned above, the application for marketing authorization shall

be refused and the fact, immediately informed in writing to the affected applicant with

appropriate justification, if:-

a) It becomes apparent that the veterinary medical products, led particularly by products

mainly intended for use in animal husbandry, for which a market authorization is being sought

would alter the balance between risks and benefits against favor of the animal health and

welfare and consumer safety,

b) the veterinary medical product for which marketing authorization is sought is found to be

either ineffective or less than capable of delivering the immunity it is intended to confer,

c) it is ascertained that the formulation would not be appropriate and in approved quality for

pharmaceutical aspects,

ç) no benefit is assessed in the product’s offering for public use,

d) it is ascertained that the length of the withdrawal period would be insufficient to

successfully eliminate any risks directed against the health of the animal to be treated and of

the public consuming the food produced from that animal or any situation to the otherwise

cannot be proven,

e) The dossier is found as not having been compiled in accordance with the relevant

guidelines,

f) The medical product for veterinary use is meant for a prohibited area of use,

g) legal preparations are in progress for providing coverage for the protection of public health,

consumer and animal health.

(6) The Directorate General shall grant the marketing authorizations to applicants whose

applications were evaluated successful, along with delivery of approved forms of leaflets

and/or package labels. The Directorate General shall publish a brief summary of

characteristics of the product for which it has granted a marketing authorization, as well as the

product itself, at its official website.

(7) The Directorate General may, in exceptional cases and in consultation with the applicant,

render the grant of marketing authorization conditional upon fulfillment by the applicant of a

requirement concerning the safety of the product and immediate notification of any adverse

event occurring with its use and indication of necessary measures in response thereto.

Recourse may be made to such procedures for granting of marketing authorizations for

objective and demonstrable reasons.

Committee for evaluation of veterinary medical products

ARTICLE 16 – (1) The Ministry will set up and implement a committee from among people

having specialized knowledge on medical products for veterinary use, to evaluate, assess and

direct marketing authorization applications made in respect thereof. (Abrogated

sentence:OJ-20/12/2014-29211) (…)

(2) The Committee will carry out the following duties:

a) Establish its own working and decision-making rules,

b) Evaluate and assess and draw and submit proposals for refusal, revocation and/or

suspension of and/or changes in other relevant matters concerning applications associated

with veterinary medical products,

c) Make out and communicate opinions about products used or usable in veterinary medicine,

ç) Actively participate in joint efforts for drawing legislative acts to govern and regulate

medical products and instruments for veterinary use,

d) Where appropriate, desirable or necessary, evaluate modifications or changes relating to

veterinary medical products,

e) Fulfill such other similar duties as may from time to time or at any time be assigned to it by

the Ministry.

(3) (Amended:OJ-20/12/2014-29211) The Committee shall convene at least six times a year.

(4) Decisions as regards the marketing authorization applications will be taken by and among

those members of the committee having reviewed the application dossiers based on simple

majority of votes. Dissenting opinions, if any, will be put on record in the minutes of each

respective meeting.

(5) On consent or request of the Ministry, the market authorization holder or applicant or his

qualified representative may join the committee to submit opinions in relation to the medical

product being under evaluation.

(6) The Committee may seek information, documents or opinion, in courtesy, from competent

authorities of the states in which the medical products for veterinary use, for which marketing

authorizations have been granted or are in progress have been manufactured or hold a valid

and legitimate marketing authorization, as well as international organizations, universities and

research institutions known to conduct studies or activities in the domain. The Committee

may send invitations to people to be assigned by such entities and organizations as

aforementioned to join it in any of its meetings.

(7) The Committee will render its decisions, so as to confer upon whether acceptance and

granting of marketing authorization to application files or acceptance and granting of

marketing authorization, after any imperfections or inconsistencies found in application

dossiers are made good and without the need for re- or further consideration thereof or refusal

of applications.

(8) Decisions thus made will immediately be notified in writing to the applicant by the

Directorate General all within ten days following the relevant session of the committee

meeting. The applicants shall be obliged to follow up the status of their applications,

throughout the entire process. In the event that no objections are brought against a decision

rendered by the Committee within a period of two months advancing upon the date of award

or the committee decision is not enforced properly and promptly or any notice or notification

given in confirmation of this fact in writing within the same period, the application dossiers

not physically retained by the Directorate General shall be returned to their owners. Costs of

consignment service for return delivery of the aforesaid documents shall be borne by the

respective applicants.

(9) The Committee will grant the necessary amount of time extension to the applicant as

needed to allow it fulfill and enforce the decision taken. In case of failure of the applicant to

fulfill and enforce the decision taken by the Committee within such extended time or, within

original time, as the case may be, without any request moved for an extension, the

applications will be returned back to the applicants Application files remaining outside the

Directorate General shall be returned to their owners. Costs of consignment service for return

delivery of the aforesaid documents shall be borne by the respective applicants.

Sales authorization, pharmacovigilance manager and competent pharmacovigilance

service institution

ARTICLE 17 – (Amended along with the heading:OJ-20/12/2014-29211)

(1) The marketing authorization holders will assign and appoint a veterinarian, who serves on

full time basis within its organization, to be their respective pharmacovigilance manager to

carry out and finalize pharmacovigilance studies and related efforts concerning their products,

with a view to obtain sales authorizations, or will have the pharmacovigilance service

institution, authorized by the Ministry, carry out such studies. In the event that such

pharmacovigilance services are ensured to be carried out by any competent service institution,

then the following principles shall be applicable.

a) In case of procurement of the service from any competent authority, the marketing

authorization holders will assign and appoint a veterinarian, who serves within its

organization, to be their respective pharmacovigilance manager.

b) The labor contract for procurement of services, as approved by a notary public, will be

submitted to the Ministry.

c) Procurement of services shall not relieve the marketing authorization holder of her/his

respective liability.

ç) Competent pharmacovigilance service institutions shall notify the Ministry of the

termination of the labor contract, within a period of thirty days. Pharmacovigilance service

institutions, which have failed to make the notification as aforementioned within the permitted

time frame, shall be first warned about the matter, and in case of repetition thereof, the

authorizations of the service institution shall be canceled.

d) In case of termination of the service procured from any competent pharmacovigilance

service institution, the marketing authorization holders shall notify the Ministry of the matter,

within thirty days following termination of the service. The sales authorizations granted to all

veterinary medical products of the marketing authorization holders, which have failed to make

the notification as aforementioned within the permitted time frame, and which do not assign

and appoint a new pharmacovigilance manager, shall be suspended, and market release

authorization shall not be granted for the veterinary medical products until a new manager is

duly elected and appointed to fill the position.

(2) Competent pharmacovigilance service institutions shall carry out the following matters in

respect of their activities.

a) Competent pharmacovigilance service institutions shall assign and appoint a veterinarian,

who serves on full time basis within its organization, to be their respective pharmacovigilance

manager to carry out pharmacovigilance studies on behalf of the marketing authorization

holders.

b) The procedures and principles of operation of the competent pharmacovigilance service

institutions and the matters regarding their audits are required to comply with the guidance

drawn up by the Ministry.

c) Pharmacovigilance service institutions, whose activities are suspended, or whose

authorizations are canceled, shall be announced by the Ministry.

(3) The marketing authorization holders and the competent pharmacovigilance service

institutions shall apply to the Directorate General with such information and documents as

hereinafter delineated, in relation to their pharmacovigilance managers, who will serve within

their organization:

a) A petition covering the Republic of Turkey ID Number, residence declaration, work

telephone and fax numbers and e-mail addresses of the pharmacovigilance

manager/competent pharmacovigilance manager,

b) Where the applicant is a legal person, original copy of the labor contract of the related

professional, as approved by a notary public, which clearly states that he is employed as a

pharmacovigilance manager/competent pharmacovigilance manager and in such capacity, will

be in charge of activities falling within the framework of related legislative acts,

c) In case of legal persons, a valid and up-to-date certificate obtained from related public

agency, indicating that the pharmacovigilance managers/competent pharmacovigilance

managers appointed for duty therein are insured according to the effective laws, and currently

working for such persons,

ç) The up-to-date and valid certificate of registration to the professional chamber, to which the

pharmacovigilance manager/competent pharmacovigilance manager is registered, and two

passport photographs and the circular of signature of the same.

(4) If one of the owners or partners of the applicant in the form of a legal person has been

appointed to be the pharmacovigilance manager/competent pharmacovigilance manager, then

the labor contract as approved by a notary public shall not be required.

(5) Pharmacovigilance managers should be selected from among the individuals other than

the responsible manager and the people assuming responsibilities for production and quality

control at manufacturing sites as well as the marketing authorization manager. The

pharmacovigilance and marketing authorization manager of the products, which are used in

case of procurement of service from any competent pharmacovigilance service institution, or

for the animals that are non-food producing, may be the same person. If the marketing

authorization holder for veterinary medical products is also the owner of the manufacturing

site where the product is being manufactured, then permission can be granted for the same

person to fulfill the positions of both pharmacovigilance and marketing authorization manager

of the same manufacturing site, having due regard to the number of marketing authorizations

held and volumes of sale realized. The marketing authorization holder may appoint different

persons for assuming responsibilities for different medical products. The Ministry may

require, by mandate, the appointment of more-than-one persons to assume responsibilities

depending on the number of authorized medical products for which a sales authorization is

sought.

(6) If the information and documents supplied on the pharmacovigilance manager/competent

pharmacovigilance manager are found in compliance with the requirements laid down herein,

the Directorate General shall issue a certificate in the name of the marketing authorization

holder/pharmacovigilance service institution and manager. Such certificates may replace the

documents sought under second paragraph hereof, in time of subsequent applications.

(7) The pharmacovigilance manager/competent pharmacovigilance manager will notify the

Ministry, of his resignation, all in one month of his quitting office. If he fails to do so and this

fact is ascertained, the pharmacovigilance manager in default will not be permitted by the

Ministry to assume office as manager in charge of veterinary medical products for two years

following his resignation or departure from office.

(8) If the pharmacovigilance manager/competent pharmacovigilance manager resigns from

office, the marketing authorization holders will have to inform the Ministry in later than one

month of his departure from office, in addition to elect and appoint another person to replace

his position. Otherwise, the sales authorizations granted to all veterinary medical products of

the marketing authorization holder shall be suspended; and market release authorization will

not be granted for the veterinary medical products until a new manager is duly elected and

appointed to fill the position; and operating authorizations of the service institution shall be

suspended until a new manager is duly elected and appointed to fill the position.

(9) Legal person authorization holders will lodge with the Directorate General, a valid and up-

to-date letter of the Social Security Institution, which demonstrates that their respective

pharmacovigilance managers/competent pharmacovigilance managers continue to hold this

position in January of each year. Those authorization holders failing to make this notification

shall be warned and given a one month period to comply. New sales authorizations for

products of those marketing authorization holders, who have failed to make the notification as

aforementioned within the permitted time frame, shall be retained; and placement on the

market of the veterinary medical products for which sales authorizations have been granted

shall be ceased, if and when required; and the operating authorizations of service institution

shall be suspended.

Issues of Sales Authorizations for veterinary biological products

ARTICLE 18 – (1) (Amended sentence:OJ-20/12/2014-29211) The marketing

authorization holders will file separate applications with the provincial directorate, for each

batch of biological veterinary medical products, which are manufactured in Turkey, or import

quantities of each batch of biological veterinary medical product manufactured abroad, for use

during checks and inspections for the granting of sales authorizations prior to placement of

the products on the market, along with:

a) an application letter wherein the product packaging and dosage amounts for administration,

the batch number and expiry date of the product are specified,

b) photocopy of the document issued by the Directorate General for the pharmacovigilance

manager,

c) the certificate of analysis belonging to the medical product from which prepared samples

are to be taken in pursuance with the instructions of the Ministry.

(2) As a result of examination of application files, the officials of the provincial directorate

will take samples from the medical products in question, acting in line with the guidelines to

be provided by the Ministry.

(3) The officials of the provincial directorate shall then send the samples they have taken to

the Biological Veterinary Medical Product Surveillance Center, along with applicable

certificate of analysis and other forms specified in the guidelines. Costs of consignment

service for return delivery of the aforesaid documents shall be borne by the respective

applicants.

(4) Following examination of the certificates of analysis issued to and testing of samples from

the medical product having been sent, at the Biological Veterinary Medical Product

Surveillance Center upon completion of other necessary assessments, those medical products

which are found eligible will receive issues of sales authorizations by the institute directorate

with which the aforesaid Center is affiliated.

(5) Medical products of the type described herein, the samples of which have not been

subjected to tests and controls at the Biological Veterinary Medical Product Surveillance

Center shall be tested and verified for compliance by another institute directorate to be

appointed by the Ministry. The Institute Directorate performing the tests and controls shall

draw up a report that shows product compliance and submit the same to the Biological

Veterinary Medical Product Surveillance Center. The sales authorizations for products

included in such report as aforementioned will be granted by the institute directorate with

which the foregoing Center of Surveillance is affiliated.

(6) Also, the report showing the tests conducted on the product(s) for granting of sales

authorization and their respective results and findings shall be sent to the applicant, together

with the sales authorization. Information on products for which a sales authorization has been

granted will be communicated to the Directorate General.

(7) As regards the sales authorizations of products not being subjected to tests and controls for

the granting of sales authorization at the Biological Veterinary Medical Product Surveillance

Center or another Institute Directorate, the tests and controls to be performed at testing and

control laboratory premises of the manufacturer will be attended physically by a veterinarian

appointed by the Biological Veterinary Medical Product Surveillance Center, as an observer.

The sales authorizations for products validated at this stage will be granted by the institute

directorate with which the foregoing Center of Surveillance is affiliated.

(8) (Amended:OJ-11/1/2013-28525)(1) The reports on products found non-compliant at the

end of quality controls performed for the granting of the sales authorization shall be sent to

the marketing authorization holder. If the marketing authorization holder raises an objection

within seven days following the date of service of notification of the report, then the product

may be subjected to a second control. The results of a second control to be performed

consequent to such objection shall be deemed final and binding. Products found non-

compliant shall be disposed of under supervision of personnel of the provincial directorate. If

the product has been imported, and upon request of the marketing authorization holder, any

non-conforming products may be returned to the country where they have been sent from. A

duly signed and approved photocopy of the record on the disposal procedure shall be

communicated to the Institute Directorate to which it is affiliated.

Issues of sales authorizations for other veterinary medical products

ARTICLE 19 – (1) (Amended:OJ-20/12/2014-29211) The sales authorizations to be granted

for medical products other than biological veterinary medical products in respect of each

different commercial presentation form before initial placement on the market shall be issued

by the Directorate General.

(2) Market authorization holders will apply to the Directorate General with ready-made

samples of the product, if required, once the quality control results become available for

manufactured or imported medical products. The Directorate General shall examine the

application and instruct the provincial directorate of the place where the products are found to

conduct sampling for testing for validation and control, from supplied product

batches. (Insertion:OJ-20/12/2014-29211) The products, a different commercial presentation

form of which has been analyzed previously, may not be re-analyzed if it is deemed

appropriate by the Ministry.

(3) The Directorate General will issue sales authorizations for products found to be compliant

at the end of these controls.

(4) Results concerning those products found to be non-compliant shall be notified to the

authorization holder. Any objections to be raised against the results shall be subjected to an

assessment in accordance with Article 85 of this Regulation. The ownership of the medical

products which have been found non-compliant at the end of tests and analyses shall pass to

the State for their due disposal. The Ministry shall grant a second opportunity for marketing

authorization holders to obtain sales authorizations for their medical products for veterinary

use. If the resultant findings of the secondary tests and controls performed on the said

products yield negative, then the marketing authorizations readily granted for the same

products shall be revoked, and the title of existing batches will pass to the State for their due

disposal. The charges of tests and controls conducted for the granting of sales authorizations

shall be borne solely by the marketing authorization holders, at their own risk and account.

(5) Following the initial sales authorization, the sales authorizations for each batch of

products either manufactured or imported from other countries shall be issued by the

marketing authorization manager. The marketing authorization manager will perform the

whole set of checks and controls as necessary before placement of the product on the market,

guaranteeing that the product meets all the requisites for authorization and has undergone all

administrative and technical processes specified in relation to it. The marketing authorization

manager should keep the sales authorizations granted for each batch for a period of at least

five years and make information relating to each batch available for inspection by the

Ministry, on request.

(6) (Insertion:OJ-20/12/2014-29211) The Ministry will have each batch of the products, to

which the certificates of Good Manufacturing Practice have not been granted by the Ministry,

or which have been manufactured at the facilities situated at the countries that have not

executed a mutual-recognition agreement, analyzed as in the first batch, before placement of

each batch of such products on the market, if and when so required.

Liabilities of the marketing authorization holder

ARTICLE 20 – (1) In addition to strictly observing the provisions of all applicable laws and

regulations in effect, the marketing authorization holder will particularly be liable for:

a) informing the Ministry in writing at a suitably prior time, on each and every change it plans

to cause in the information and documents originally submitted for the granting of marketing

authorization,

b) providing response to the Ministry within periods allowed for the purpose, whenever

information is requested on the product by the latter,

c) Informing the Ministry of any updates in the world concerning the use, restriction or

revocation of the veterinary medical products and starting materials,

ç) Retaining in safe custody and permanently up-to-date, in such a way that allows tracking

and inspections for five years of any and all records required by the Ministry and furnish the

same with any and all kinds of information and documents requested, in a timely manner,

d) ensuring that samples are taken by the Ministry as desired for testing and controls,

e) manufacturing or having manufactured in accordance with the information supplied in time

of the granting for marketing authorizations for veterinary medical products, carrying out or

letting others carry out the quality checks and controls of each manufactured batch and

keeping a close track of all contemporaneous scientific and technical progress related with

these matters and adapting to them, when necessary,

f) Affording the supply of necessary materials as required by the Ministry for identification of

residues and for the performance of quality controls on veterinary medical products,

g) Once after the placement of the veterinary medical product on the market, carrying out any

and all activities concerning efficient and safe use of the product, especially tracking the

adverse effects of the products, putting on record the resultant findings and complaints and

reviewing and evaluating reports and their findings with a view to communicate the results to

the Ministry and owners of the complaints, if applicable,

ğ) Paying the charges and fees as ascertained by the Ministry for application to grants of

authorizations, amendments caused therein, certificate renewals, reviews and controls,

h) Ensuring that the products retain anticipated quality and are dispensed in appropriate

conditions,

ı) If required, providing specialized technical support in relation to analytic methods

applicable for testing and analyses of the products and their residues,

i) (Amended:OJ-11/1/2013-28525)(1) Ensuring that samples, at the quantity determined by

the Ministry, from each batch manufactured or imported, are retained,

j) Ensuring that any products, which are unusable or which have become deprived of being

usable, are disposed of in accordance with the relevant regulations.

(2) The granting of a marketing authorization for a particular veterinary medical product by

the Ministry shall not release or relieve the marketing authorization holder from any liabilities

or obligations. The liabilities and obligations referred shall continue to be in effect also after

placement of the product on the market.

(3) The responsibility for authenticity and validity of all information and documents

submitted to the Ministry shall rest with the applicant.

(4) (Amended:OJ-20/12/2014-29211) Any change or modification in the products authorized

abroad shall be immediately notified to the Ministry.

CHAPTER THREE

Manufacturing Sites of Veterinary Medical Products

Authorization requirement

ARTICLE 21 – (Amended:OJ-20/12/2014-29211)

(1) The manufacturing processes of veterinary medical products shall be carried out in

compliance with the marketing authorizations at manufacturing sites authorized pursuant to

the provisions of this Regulation. However, at manufacturing sites holding valid licenses

issued by the Ministry of Health, veterinary medical products can be manufactured, with the

exception of biological ones, within the framework of the marketing authorization granted,

provided that the Ministry is informed about the activity. The veterinary medical products

available in the categorization of the external ectoparasites, may be manufactured at the

facilities, which have obtained authorizations for manufacturing the plant protection products,

provided that the requirements specified under the good manufacturing practices guidance are

satisfied.

(2) At manufacturing sites authorized by the Ministry, no other goods than veterinary medical

products can be manufactured.

(3) The manufacturing authorization may be granted to any manufacturing sites, where all

activities for the pharmaceutical ingredients and finished products are carried out, as well as

to any facilities, where one or several of the manufacturing processes such as manufacturing

of bulk products, filling, partition, auxiliary packaging activities, quality control and batch

release is/are conducted.

(4) The requirements of good manufacturing practices shall be sought upon the stage of pre-

clinical development within the life cycle of any veterinary medical product. However, the

authorization for site works of any veterinary medical product, which is at the stage of

research and development, will be obtained from the Ministry. The Ministry may grant

authorization to the manufacturing sites in respect of importation of veterinary medical

products, active substances, packaging materials, microorganism culture, in order to be used

during the research and development activities.

(5) The areas covered by the manufacturing authorization may not be used for the activities

such as veterinary pharmaceutical warehouse and retail sales points.

(6) The facilities, where the products for which a marketing authorization has been granted in

Turkey are manufactured, including the ones for exporting purposes, as well as the personnel

and activities of such facilities should comply with the good manufacturing practices

guidance for veterinary medical products.

Responsible manager

ARTICLE 22 – (1) Manufacturers intending to obtain manufacturing authorizations for their

manufacturing sites or premises should appoint and ensure employment, on a full-time regular

basis, of a responsible manager having received satisfactory formative training and field

experience in one of the professional categories specified in Section 12 of the Law. The

responsible manager should provide documentary proof of the facts that he has worked for at

least two years in a manufacturing site or premise that produces medical products for human

or veterinary use under a valid and effective authorization and that he actually possesses

experience and knowledge in areas relating to quality testing of products and quantitative

analyses and controls of starting materials.

(2) The manufacturing site authorization holder may fulfill the tasks and responsibilities

defined for the position of responsible manager himself, if he meets or exceeds the above

mentioned requisites.

(3) The responsible manager shall mainly be liable for:

a) ensuring the conduct of all activities within the site or premise in compliance with the

applicable laws,

b) ensuring the due and complete keeping of records led by dates of production, names of

products, quantities supplied and names of recipients and manufacturer’s batch numbers,

c) ensuring that all products manufactured possess the required levels of quality and

characteristics as specified in the marketing authorization file and for the purpose,

guaranteeing that all tests and analyses are performed.

Granting of Authorization

ARTICLE 23 – (1) Whoever intends to obtain a manufacturing authorization for medical

products for veterinary use shall apply to the Ministry, together with the following

information and documents:

a) Full address,

b) Site location on the city or town plan, if available,

c) Building and floor plans,

ç) Commercial Registry papers indicating the registered domicile of the corporate applicant,

its founding objectives, partnership structure and responsible people together with description

of their respective duties, positions, titles and signatory capacities,

d) Sketches illustrating production flow charts (the class of ventilation provided will be

marked on the sketches)

e) information on activities performed at the manufacturing facility,

f) detailed information on production and pharmaceutical forms being manufactured,

g) listings of machinery, equipment and instrumentation employed for such activities as

production, quality control and etc.,

ğ) particulars of the plumbing and ventilation system, together with a sketch layout.

(2) Applications qualified at the end of the examination will receive preliminary

manufacturing site authorization, while, for those not qualified, the applicants will be

informed of the non-conformities and defects found.

(3) Those applicants who have managed to obtain a preliminary manufacturing authorization

will complete and submit to the Ministry, in the attachment of their applications covering their

representations that they will carry out their manufacturing procedures in strict compliance

with good manufacturing practices, to obtain a manufacturing authorization for their

veterinary medical products:

a) (Amended sub-paragraph:OJ-11/1/2013-28525)(1) With regards to the responsible

manager, quality control manager and quality assurance manager:

1) An up-to-date and valid certificate of registration to the professional chamber given by the

professional chamber, to which such person is registered, and if there is no any such chamber

for that profession, then the copy of the diploma or certificate of graduation of such person,

two passport photographs and the circular of signature of the same,

(2) A petition covering the Republic of Turkey ID Number, residence declaration, work

telephone and fax numbers and e-mail addresses of such person,

3) letter undertaking that they agree and acknowledge their respective roles and

responsibilities,

4) other documents showing experience in the relevant area or domain,

5) original copy of the labor contract of the related professional, as approved by a notary

public, which clearly states that the professional in question is employed as a responsible

manager and in such capacity, will be in charge of activities falling within the framework of

related legislative acts, and that such person is insured as per the legislation.

b) As regards the manufacturing site and manufacturer:

1) Products that should be manufactured in reserved/isolated areas,

2) Products manufactured, analyzed or etc., under contracts, by assigned third parties,

3) Activities like production, analysis etc., performed by assigned third parties under contract,

4) Original or notary certified duplicate copy of the Non-Sanitary Enterprise License,

5) (Amended:OJ-20/12/2014-29211) The positive Environmental Impact Assessment

Decision for manufacturing site of the active substance of the veterinary medical products, the

positive Environmental Impact Assessment Decision for manufacturing site of the veterinary

medical products other than veterinary biological products, or the decision prescribing that

environmental impact assessment is not required,

6) Cashier receipts confirming full remittance of related duties and charges.

c) Where managers fulfill their roles and duties as part of a team, information on personal

identities, experiences and levels of education of team members.

(4) (Amended:OJ-20/12/2014-29211) Application documents shall be assessed within a

period of ninety days following submission of the same to the Ministry, and the compliance of

any information and documents submitted during the application process shall be reviewed. In

case of detection any deficiencies, the applicant shall be provided with feedback, and shall be

requested to eliminate such deficiencies. In respect of the applications deemed appropriate,

the applicant shall be notified of the fact that s/he is required to apply for the certificate of

good manufacturing practices. The actions to be taken in order to obtain the certificate of

good manufacturing practices shall be determined by the Ministry. Both manufacturing

authorization and the certificate of good manufacturing practices shall be granted to the

facilities deemed appropriate as a consequence of the on-site inspection.

(5) Those applicants who intend to obtain a manufacturing site authorization for veterinary

medical products without first receiving a preliminary authorization, should provide all the

documents specified in first and third paragraphs of this article.

(6) (Amended:OJ-20/12/2014-29211) The health protection strip applicable at the sites,

where biological veterinary medical products are manufactured and controlled, shall be

applied taking into account the micro-organisms to be employed and bio-safety measures

taken at the manufacturing site. The manufacture and control of the microorganisms and the

necessary characteristics of the areas, where experimental animals to be used for such

activities are kept, and the bio-safety requirements and categories shall be determined by the

Ministry.

(7) The manufacturing site authorization shall be granted for the manufacturing site and

pharmaceutical forms actually mentioned in the application, only. The manufacturing sites are

obliged to fulfill the requirements of new arrangements as may subsequently be made by the

Ministry after the granting of authorization. The Ministry shall provide the authorization

holders with appropriate time to carry out this extra procedure for compliance with the new

arrangements

(8) Manufacturing sites which have to use experimental animals in their production or testing

and control cycles must have obtained in advance the necessary set of authorizations from the

Ministry, as foreseen by the applicable laws, regarding the experimental animals in question,

before applying for a manufacturing authorization.

(9) The approval of the Ministry should be sought for any and all changes to be made at the

manufacturing site. The Ministry will conclude its review and assessment on each request of

change reaching at it, all within thirty days of its first receipt thereof. This period may be

extended to ninety days, when circumstances would so require. For initial applications and

change requests, the time consumed to consummation of defects by the applicant as required

shall not be included in the time count for the above set period of ninety days.

(10) (Amended:OJ-20/12/2014-29211) The inspection and certification of the manufacturing

sites situated in Turkey and abroad in respect of the good manufacturing practices will be

performed at cost of the respective applicants.

(11) (Amended:OJ-11/1/2013-28525)(1) Manufacturing site authorization holders may

request registration of conformance of their manufacturing sites and the products they

manufacture in them, with good manufacturing practices.

Obligations of the Manufacturing Site Owners

ARTICLE 24– (1) The obligations of the manufacturing site owners shall be, as follows:

a) to hire labor in necessary quantities and with required qualifications to ensure conduct of

manufacturing, control, storage and dispensing of veterinary medical products in accordance

with the applicable law provisions,

b) to inform and get permission from the Ministry with respect to all administrative and

technical changes involving the manufacturing site.

c) to inform the Ministry immediately, of the responsible manager’s inability or unavailability

to perform his roles and duties or his resignation from office.

ç) to provide all reasonable access and assistance to auditors appointed by the Ministry in time

of conduct of their audits and inspections on the premises.

d) to make all arrangements and take all reasonable measures as necessary for rendering the

responsible manager able to fulfill his role and duties arising out of or in connection with his

position.

e) to strictly abide by and follow principles on good manufacturing practices of veterinary

medical products and at all times select, prefer and use exclusively such active substances that

completely accord with good manufacturing practices as starting materials.

f) To fulfill the requirements of instructions and guidelines to be enacted in pursuance of the

provisions of this Regulation.

g) to pay in full all duties and charges stipulated in the applicable law, on matters that require

authorization or approval of the Ministry, such as manufacturing site authorizations, changes

and etc.

Quality management

ARTICLE 25 – (1) The manufacturer shall establish and implement an effective

pharmaceutical quality assurance system, involving the active participation of the

management and personnel of the different services involved.

Personnel

ARTICLE 26 – (1) (Amended:OJ-20/12/2014-29211) It shall employ the persons assuming

responsibilities for production and quality control at manufacturing sites other than the

responsible manager, as well as any other personnel. In respect of the personnel, the following

matters should be satisfied.

(2) (Amended:OJ-20/12/2014-29211) The responsible manager, production, quality

assurance and quality control managers are obliged to attend physically at the manufacturing

site during the activities and fulfill such responsibilities as laid down in this Regulation. In

cases where the responsible manager, production, quality assurance and quality control

manager may not attend work, the manufacturer shall appoint people with identical or similar

qualifications to hold office temporarily in proxy and document this fact. Should the entire

duration of such temporary replacement exceed a total of ten days, he will inform the

Directorate General. In cases of duty vacations for more than two months, a new manager

should be appointed to positions to be vacated, on consent of the Ministry.

(3) If any of the aforementioned managers are found not attending work personally during

conduct of auditory inspections, the missing persons shall be warned. Any official receiving

warnings for not attending work for more than twice in any given year shall be suspended

from office indefinitely. The person whose duty and position as responsible manager have

been terminated for reasons described above will be banned by the Ministry from holding

office in peering positions involving or concerned with veterinary medical products, for at

least a period of two years from the date of his departure from office.

(4) If the responsible manager resigns from office, the manufacturer will have to inform the

Ministry immediately of his departure from office, in addition to electing and appointing

another person in his place. The manufacturing authorizations of manufacturers who fail to

inform resignation of responsible managers and elect and appoint another person to takeover

the duty in their place will be suspended.

(5) The responsible managers will have to notify the Ministry his resignation, all in five days

of their quitting office. If they fail to do so and this fact is ascertained by evidence, the

responsible managers in default will not be permitted by the Ministry to assume office as

such, in charge of veterinary medical products for two years to elapse following their

resignation or departure from office.

(6) For changes in manager positions, the newly appointed manager will be made known to

the Ministry, with submission of documents specified in article 23 hereof and its consent

sought and obtained in return.

(7) As all stages of the manufacturing process need to be implemented under supervision and

directions of managers, if either one of them does not attend his duty for any reason

whatsoever, no production can take place, except with reservation of provisions of the

paragraph relating to delegation by way of proxy.

(8) (Amended:OJ-20/12/2014-29211) The manufacturing site will have to lodge with the

Directorate General, a valid and up-to-date letter of the Social Security Institution, which

demonstrates that their respective managers continue to hold this position in January of each

year. Those manufacturing sites failing to make this notification shall be warned and granted

an additional one month period. The manufacturing authorization of the facility failing to

make this notification as aforementioned within the permitted time frame shall be suspended.

Premises and equipment

ARTICLE 27 – (1) As regards premises and equipment;

a) Premises and manufacturing equipment shall be located, designed, constructed, adapted

and maintained to suit the intended operations,

b) Layout, design and operation must aim to minimize the risk of errors and permit effective

cleaning and maintenance in order to avoid contamination, cross contamination and, in

general, any adverse effect on the quality of the product,

c) Premises and equipment intended to be used for manufacturing operations which are

critical for the quality of the products shall be subjected to appropriate qualification.

Documentation

ARTICLE 28 – (1) As regards documentation, the following rules shall apply:

a) The manufacturers shall establish a system of documentation covering the different

manufacturing operations that they perform. Documents shall be retained clear, free from

errors and kept up to-date. Pre-established procedures for general manufacturing operations

and conditions shall be available, together with specific documents for the manufacture of

each batch. This set of documents shall make it possible to trace the history of the

manufacture of each batch. The batch documentation shall be retained for at least one year

after the expiry date of the batches to which it relates, or at least five years after the date of

expiry of the batch, whichever is the longer. Documents submitted to the Ministry in support

of application for a product authorization and updated initially and subsequently shall be

retained until the authorization is revoked.

b) When electronic, photographic or other data processing systems are used instead of written

documents, the manufacturer shall have validated the system by proving that the data will be

appropriately stored during the anticipated period of storage. Data stored by these systems

shall be made readily available in legible form. The electronically stored data shall be

protected against loss or damage of data (e.g. by duplication or back-up and transfer onto

another storage system) for further submission to the Ministry in writing, upon request.

Production

ARTICLE 29 – (1) The different production operations shall be carried out according to pre-

established instructions and procedures and in accordance with good manufacturing practice.

Adequate and sufficient resources shall be made available for the in-process controls.

Appropriate technical and/or organizational measures shall be taken to avoid cross

contamination and mix-ups. Any new manufacture or important modification of a

manufacturing process shall be validated. Critical phases of manufacturing process shall be

regularly revalidated.

(2) For purposes intended in this Regulation, all aspects relating to production of active

substances subject to use as starting materials and all processes before the product enters in

composition including whole or partial production of active substances, exportation,

separation, packaging and labeling procedures.

Quality control

ARTICLE 30 – (1) The quality control will be carried out within the framework of the

following requirements:

a) (Amended:OJ-20/12/2014-29211) The manufacturing site shall establish and maintain a

quality control department. This department shall be placed under the authority of a person

having the required qualifications and shall be independent of the other departments. The

quality control manager should possess experience for at least two years in a manufacturing

site or premise that produces medical products for human or veterinary use under a valid and

effective authorization in respect of areas relating to quality testing of products and

quantitative analyses and controls of starting materials.

b) The quality control department shall have at its disposal one or more quality control

laboratories appropriately staffed and equipped to carry out the necessary examination and

testing of starting materials, packaging materials and intermediate and finished products

testing. Resorting to outside laboratories is authorized, provided that a contract manufacturing

agreement is entered by and between manufacturers and exporters for arranging the conduct

of certain tests and controls of production at laboratories outside the manufacturing site,

where responsibilities of both parties mutually against each other and against the Ministry are

explicitly defined.

c) During the final control of finished products before their release for the sale or distribution,

in addition to analytical results, the quality control department shall take into account

essential information such as the production conditions, the results of in-process controls, the

examination of the manufacturing documents and the conformity of the products to their

specifications (including the final finished pack).

ç) (Amended:OJ-20/12/2014-29211) The finished product sample, starting materials used for

the production of the batch and packaging material should be kept for a period of time and in

quantities specified under the good manufacturing practices guidance for each batch product

placed on the market.

Work contracted out

ARTICLE 31 – (1) Work contracted out shall be carried out according to the following

provisions:

a) Any manufacturing operation or operation linked with the manufacture which is carried out

under contract, shall be the subject of a written contract between the contract giver and the

contract acceptor.

b) The contract shall clearly define the responsibilities of each party and in particular the

observance of good manufacturing practice by the contract acceptor and the manner in which

the qualified person responsible for releasing each batch shall undertake his full

responsibilities.

c) The contract acceptor shall not further sub-contract any of the work entrusted to him by the

contract giver without the written authorization of the contract giver.

ç) The contract acceptor shall respect the principles and guidelines of good manufacturing

practice and shall submit to inspections carried out by the competent authorities.

Complaints and product recall

ARTICLE 32–(1) The manufacturer shall implement a system for recording and reviewing

complaints together with an effective system for recalling promptly and at any time the

veterinary medical products in the distribution network. Any complaint concerning a quality

defect shall be recorded and investigated by the manufacturer. The Ministry shall be informed

by the manufacturer of any quality defect that could result in a recall or abnormal restriction

on the supply. Any recall taking place in the foregoing manner shall be informed by the

Ministry to other countries where the product has been exported.

Self-inspection

ARTICLE 33 – (1) The manufacturer shall conduct repeated self-inspections as part of the

quality assurance system in order to monitor the implementation and respect of good

manufacturing practice and to propose any necessary corrective measures. Records of such

self-inspections and any further corrective action shall be maintained.

CHAPTER FOUR

Whole and Retail Sale of Veterinary Medical Products

General Requirements on Sales

ARTICLE 34 – (1) (Amended:OJ-11/1/2013-28525)(1) The wholesale of veterinary medical

products, excluding any veterinary biological products, may be carried out Ministry licensed

veterinary pharmaceutical warehouses, pharmaceutical warehouses operating under license

issued by the Ministry of Health, and retail sales of the same may be carried out at

pharmaceutical warehouses and clinics and animal hospitals that have obtained retail sales

license for veterinary medical products from the Ministry as per the provisions of this

Regulation. No veterinary medical product sales can take place at locations other than those

specified, including the Internet. Clinics, polyclinics and hospitals must seek and obtain a

retail sales authorization also for veterinary medical products intended for use in animals

served by them even for purposes other than resale.

(2) (Amended:OJ-20/12/2014-29211) At the workplaces where ornamental birds, aquarium

fish and exotic decoration animals are put on sale under authorization, only the veterinary

medical products, other than veterinary biological medical products, that are specific to these

animal species can be sold However, such places should possess and meet the requirements

given under Article 35. Such places shall not be allowed to perform product sales until they

possess and meet the prescribed requirements. Such places are required to keep records, and

to act in compliance with the instructions and guidance materials published by the Ministry.

(3) The Ministry may impose special extensions on the conditions of sale and use of certain

veterinary medical products, which may potentially affect human, animal and environmental

health adversely.

(4) (Amended:OJ-11/1/2013-28525)(1) Product authorization holders may not assign to any

third parties, use for any purposes other than intended, or carry out the trading of the starting

materials they have supplied for the purpose of manufacturing their products.

(5) No products or compounds may be prepared at any sales points, and the products may

only be sold in their final sale presentation forms as submitted for the granting of marketing

authorization and not in such a manner that deteriorates the integrity of their immediate

packaging.

(6) All sales points will have to monitor whether or not the products they put on sale have

marketing and sales authorizations. No sales or distribution of batches that reportedly contain

unauthorized, fake, imitated or already expired veterinary medical products or products with

opened packages or decomposed or decaying products will be allowed at the sales points. If

any violation is detected, such products will be removed outside the sales point, and the

situation shall be notified immediately to the provincial directorate, and action shall be taken

according to the instructions given. In case of detection of products not reported on sales, the

Ministry will start required set of action against the sales points.

(7) (Amended:OJ-20/12/2014-29211) The marketing authorization holders of veterinary

medical products, excluding any veterinary biological products, may distribute their products

only to the veterinary pharmaceutical warehouses and pharmaceutical warehouses operating

under the license issued by the Ministry of Health. The marketing authorization holders shall

keep the products only at the manufacturing site where they have been manufactured or

representative veterinary pharmaceutical warehouses.

(8) The Ministry may block any intended or actual sale or transfer of products to wholesalers

and retailers which fail to fulfill the requirements of this Regulation.

(9) Marketing authorization holders, sales points or persons authorized to purchase veterinary

medical products for their own use may not give away or donate or otherwise dispense, free of

charge, any veterinary medical products to ranches, animal owners and livestock breeders and

other undertakings lacking sales authorizations, for such reasons as provision of benefits in

benevolence to, promotion or supporting of a community or business.

(10) Pharmaceutical warehouses and pharmacies selling veterinary medical products under

license provided by the Ministry of Health shall be obliged to fulfill the provisions of this

Regulation.

(11) (Insertion:OJ-11/1/2013-28525)(1) Excluding any veterinary products for human use,

and any plant protection products, any persons who possess and keep, import, export or carry

out trading of any substances efficient in terms of anabolic, anti-infectious, anti-parasitic, anti-

inflammatory, hormonal or psychotropic substances, and which are used at manufacturing of

any starting materials to be used at manufacturing of any veterinary medical product or

product, shall be accountable to the Ministry, and shall be obliged to keep any and all records

regarding the trading of their products in details, and to retain such records for a period of at

least three years, in order to submit the same to the Ministry, when and if required.

(12) (Insertion:OJ-11/1/2013-28525)(1) The marketing authorization holders, manufacturing

sites, veterinary pharmaceutical warehouses, locations authorized to carry out retail sales, and

any livestock enterprises authorized by the Ministry for wholesale of veterinary medical

product supply shall be obliged to comply with the written and electronic monitoring systems

determined by the Ministry, and to establish the required infrastructure for such purpose. The

marketing, manufacturing site, retail sales point or wholesale supply authorizations or

veterinary pharmaceutical warehouse licenses of any persons, who have not fulfilled to

perform the required actions with respect to the monitoring systems within the period granted

by the Ministry, shall be suspended until the necessary requirements are met and satisfied. In

respect of any and all applications for authorizations and licenses to be submitted as of the

date of effect of the monitoring system, the requirements of the monitoring system shall be

sought in addition to the application requirements.

(13) (Insertion:OJ-20/12/2014-29211) The sites authorized in accordance with the provisions

of this Regulation may operate under the scope of the authorization only. The sites other than

the aforementioned sites and any organizations such as associations, unions and foundations

may not purchase, sell, store and distribute any veterinary medical products.

Characteristics of Sales Points

ARTICLE 35 – (1) Every holder of the authorization for distribution of veterinary medical

products shall have at his disposal proper and sufficient equipment and physical structuring in

order to be able to pursue activities in compliance with the applicable law provisions.

(2) Principles that sales points are required to enforce and observe will be set out in a

guideline published by the Ministry through their official website. However, such isolated

sections as examination rooms, operation rooms and etc., may possess only such veterinary

medical products that are necessary for interventions.

(3) Marketing authorization holders and warehouses must abide themselves by and strictly

observe the instructions of the Ministry, and take all measures that may not adversely affect

the product characteristics in time of distribution. The distributor will be held ultimately

responsible, for this matter.

Activity scope of the veterinary pharmaceutical warehouses and the products

availability of which is compulsory

ARTICLE 36 – (Amended along with the heading:OJ-20/12/2014-29211)

(1) Any veterinary pharmaceutical warehouse shall determine its activity scope for at least

one of the following sub-paragraphs, and shall keep available the types of the veterinary

medical products under its scope, in minimum quantities determined by the Ministry. The

products, availability of which is compulsory, and quantities thereof shall be announced on

the web page of the Ministry.

a) Cattle, sheep and goat, water buffalo, equidae and bee.

b) Avian, fish and any other aquatic animals, and bee.

c) Cat and dog, and any other pets and decoration animals.

(2) Any veterinary pharmaceutical warehouse may keep available the veterinary medical

products in quantities, which it will determine, for any other species other than the ones under

its scope.

(3) The Ministry may compel the veterinary pharmaceutical warehouses to hold in stock

certain veterinary medical products that might pose importance in animal health in quantities

and for periods to be specified, either at national or regional.

(4) Any veterinary pharmaceutical warehouses shall take any required measures in order to

response the requests for veterinary medical products, which are received from the

pharmacies and from any places authorized to perform retail sales and from any other

warehouses, to the extent of their stocks, and in order to deliver the veterinary medical

products to the places requested as soon as possible and under the most favorable conditions.

(5) Any veterinary medical product manufacturing sites, any representative veterinary

pharmaceutical warehouses and any representative veterinary pharmaceutical warehouses

operating under the license issued by the Ministry of Health, and the marketing authorization

holders for veterinary biological products, additionally, shall take any required measures in

order to response the requests for veterinary medical products, which are received from the

veterinary pharmaceutical warehouses and from the pharmaceutical warehouses operating

under the license issued by the Ministry of Health, to the extent of their stocks, and in order to

deliver the veterinary medical products to the places requested as soon as possible and under

the most favorable conditions.

(6) The actions shall be taken for those who have demonstrably failed to comply with the

requirements of the fourth and fifth paragraphs of this article, in accordance with the

subparagraph (i) of the first paragraph of Article 37 of the Law.

Promotion

ARTICLE 37 – (1) Sales points should act upon the arrangements governing promotion of

veterinary medical products. Sales points may not use any expression purporting or divulge,

advertise, disclose or otherwise carry out campaigns or promotions to raise awareness among

the public on the fact that they sell veterinary medical products by making use of signboards,

posters, handouts, flyers, websites, electronic mail groups and electronic media like social

networks or tools like promotional materials. The right to promote the product rests

exclusively with the holder of marketing authorization. However, warehouses may advertise

themselves and their services provided that they only include their names and contact

information in relevant media.

(2) (Abrogated:OJ-11/1/2013-28525)(1)

Modifications and Inspection

ARTICLE 38 – (1) A holder of license/authorization intending to make major modifications

at sales points should seek for and obtain, through an application in writing supported with

documents justifying or describing such modifications, authorization from the provincial

directorate. On application, the provincial directorate will review the documents submitted to

it and grant the preliminary authorization. Right after the modification, the provincial

directorate will carry out an inspection on site and if it approves the modifications so far

made, draw up a report, according to which it shall approve the modification and inform the

applicant on results.

(2) All sales transactions will be ceased if the sales point gets damaged in great deal

threatening the safety of veterinary medical products, for such reasons as fire, earthquakes,

floods and etc. The products will be entrusted to a trustee, if the circumstances so require,

until such time when repairs / renovations are finished or legitimately put for sale, if deemed

appropriate or desirable.

Veterinary pharmaceutical warehouse opening conditions

ARTICLE 39 – (Amended:OJ-11/1/2013-28525)(1)

(1) Veterinary pharmaceutical warehouse license may be granted only to any natural persons

who are veterinary surgeons or pharmaceutists, or to the persons who employ such persons as

the responsible manager. If a warehouses is engaged in trading of veterinary biological

products, then the license may be granted to the persons, who employ a veterinary surgeon as

the responsible manager, or to the persons who are veterinary surgeons.

(2) Any logistics companies, which conduct storage and maintenance and handling and

transportation activities for veterinary medical products, shall also be obliged to obtain a

veterinary pharmaceutical warehouse license.

(3) The responsible manager at the veterinary pharmaceutical warehouses belonging to any

natural persons is the veterinary surgeon or pharmaceutist owning such warehouse. Such

natural person may employ another veterinary surgeon or pharmaceutist as the responsible

manager. Certificate of the responsible manager shall be issued and granted by the Directorate

General.

(4) Duties and responsibilities of the responsible manager shall be as follows;

a) To ensure that the activities and operations of the warehouse are carried out in accordance

with the regulations,

b) To ensure that the products are accepted, stored and shipped at the appropriate conditions,

c) To ensure that any records requested by the Ministry are kept ready for any

audits/inspections,

ç) To participate in any audits and controls/inspections to be carried out by the Ministry,

d) To provide any details and information timely as requested by the Ministry,

e) To participate in any trainings and meetings to be held by the Ministry, or the relevant

chamber of profession or any other professional association, when and if required.

f) (Insertion:OJ-20/12/2014-29211) To ensure performance of recall procedures.

(5) The responsible manager shall be obliged to be present at the veterinary pharmaceutical

warehouse during the period of its activities and operations. Before obtaining the

authorization for the responsible manager, another veterinary surgeon or pharmaceutist shall

be designated and notified to the provincial directorate, as the deputy. If the authorization

exceeds two months within a year, then a certificate of responsible manager shall be obtained

from the Directorate General for another veterinary surgeon or pharmaceutist.

(6) If the responsible managers is found not attending work personally during conduct of

auditory inspections, he shall be warned. In case of repetition of such situation, then the

certificate of responsible manager of the concerned person shall be revoked. Any warehouses,

the certificate of responsible manager of which is revoked, shall be obliged to employ a new

responsible manager within one month at the latest. The license holder shall designate the

deputy responsible manager within five business days, and shall inform the provincial

directorate about the situation. The license of any warehouse, which do not employ a

responsible manager within the period prescribed, or which do not notify the deputy, or for

which it is detected that its deputy is not present at the workplace, shall be suspended, and the

activities and operations of such warehouse shall be ceased. Any persons, whose certificate of

responsible manager has been revoked, may not be liable for any matter in relation to

veterinary medical products for a period of one year as of the date of such revocation.

(7) (Amended:OJ-20/12/2014-29211) If the responsible manager quits office, then the owner

of the warehouse and the responsible manager shall inform the provincial directorate about

such case by submitting a petition for such purposes within a period of five business days.

The owner of the warehouse shall inform the provincial directorate about a new responsible

manager within a period of fifteen business days. The licenses of warehouses failing to

comply with such periods shall be suspended until a new responsible manager is designated.

Any responsible manager, who has not submit such notice of information duly, may not

assume any responsibilities in relation to veterinary medical products for a period of one year

as of the date of her/his quitting office.

(8) Any license holders, employing responsible managers, shall be obliged to deliver the

document, stating that the responsible manager continues to hold her/his position, to the

provincial directorate, within January of each year. The licenses of any warehouses, which

fail to provide such notice, shall be suspended.

(9) (Insertion:OJ-20/12/2014-29211) The owner of the warehouse shall establish the

necessary infrastructure to ensure that the responsible manager can fulfill her/his duties and

responsibilities.

(10) (Insertion:OJ-20/12/2014-29211) There will be an administrative department, and the

product acceptance, quarantine, storage, product shipment and product rejection departments

at the veterinary pharmaceutical warehouse as separated from each other.

(11) (Insertion:OJ-20/12/2014-29211) The veterinary pharmaceutical warehouse shall

protect the veterinary medical products under the conditions specified in their labels and

leaflets.

(12) (Insertion:OJ-20/12/2014-29211) The temperature and humidity values of the storage,

quarantine and rejection departments of the veterinary pharmaceutical warehouse shall be

measured from the points determined through the validation studies on real time and non-stop

basis, and shall be monitored and recorded.

Issue of operating licenses for veterinary pharmaceutical warehouses

ARTICLE 40 – (Amended:OJ-11/1/2013-28525)(1)

(1) License applications shall be filed with the provincial directorate of the location where the

warehouse is situated, together with the following documents:

a) The petition containing the full address of the warehouse, and the telephone and fax

numbers and e-mail addresses of the responsible manager and the warehouse,

b) The Republic of Turkey ID Number of the responsible manager, and her/his residence

declaration, list of signatures and 4 passport photographs,

c) A valid and up-to-date certificate of registration obtained from the professional chamber to

which the responsible manager is registered,

ç) The layout plan showing the equipment and various sections of the veterinary

pharmaceutical warehouse,

d) development plan of the veterinary pharmaceutical warehouse,

e) Certificate of compliance in terms of safety against any fire and explosions,

f) detailed information on the other activities to be performed at the warehouse, for

representative pharmaceutical warehouses,

g) Details about the vehicles and equipment to be used by the veterinary pharmaceutical

warehouse,

ğ) If the applicant is a legal person, a commercial registry excerpt denoting the registered

address of the company, founding objectives, partnership structure and people in charge of

governance of the company, giving their respective duties, titles and signature authority

frames; and a copy of the articles of association of the company, and the labor contract stating

that the company employs the relevant professional as the responsible manager, and that such

person is responsible for the activities and operations corresponding to the scope of the

relevant legislation, and a declaration in relation to assignment of the responsible manager if

the same is a partner of the company,

h) If the applicant is a natural person, then the Republic of Turkey ID Number and residence

declaration, list of signatures of such person, and the declaration of such person if s/he wishes

to act as the responsible manager on her/his own, or if such natural person will designate

another person as the responsible manager, then the document and the labor contract

indicating that such person is being employed by the responsible manager and that s/he will

be responsible for the activities and operations corresponding to the scope of the relevant

regulations,

(2) Following it is seen that the application documents are in full and complete, the provincial

directorate shall inspect the veterinary pharmaceutical warehouse on its site within fifteen

business days. Such inspection shall be performed by at least two staff members serving at the

provincial directorate.

(3) The provincial directorate shall send the documents and the inspection report pertaining to

the veterinary pharmaceutical warehouse, deemed appropriate upon the inspection, to the

Directorate General for issuance of the license.

(4) The provincial directorate shall provide information by means of a letter, explaining the

situation, within fifteen business days, to the location which is not deemed appropriate upon

performance of such inspection, or which is detected to have insufficiencies. If such

insufficiencies are not perfected within a period of one month following the date of service of

notice of such letter, then the application shall be returned to the applicant.

(5) The Directorate General shall issue a license in two copies for any applications that are

detected to have been deemed appropriate. A copy of the license shall be sent to the applicant,

and the other copy shall be sent to the provincial directorate.

(6) If it detects any insufficiency or non-conformance in respect of any application, then the

Directorate General shall inform the provincial directorate about the situation, in order to

enable the same to notify the case to the applicant. If such insufficiencies are not perfected

within a period of one month following the date of service of notice to the applicant, then the

application shall be returned to the applicant by the provincial directorate.

Warehouse activities

ARTICLE 41 – (1) Warehouses shall not be permitted to make direct sales to end users,

whether as wholesalers or as retailers.

(2) Warehouses may distribute the products excluding veterinary biological products only to

the following locations:

a) Pharmacies,

b) veterinary clinics, polyclinics and hospitals holding retail sale authorizations,

c) Other pharmaceutical warehouses,

ç) (Abrogated:OJ-11/1/2013-28525)(1)

(3) The Ministry may allow for the supply of veterinary medical products from warehouses

through procurement contracts settled through public tendering procedures, by public

agencies and organizations providing animal health services, raising animals or somehow

related with livestock breeding, based on reports drawn up by veterinarians. (Insertion:OJ-

20/12/2014-29211) The products provided/supplied under this article may not be subject to

trading.

(4) (Amended:OJ-11/1/2013-28525)(1) (Amended sentence:OJ-20/12/2014-

29211) Livestock enterprises providing animal health services through the veterinarians, they

employ on full-time basis within their organizations, including those publicly owned, may

obtain products from the warehouses, provided that the approval of the Ministry has been

obtained. However, such medical products may only be administered to the livestock owned

by such enterprises. These enterprises may not sell or distribute these products to any third

persons for whatsoever reasons. Matters relating to this paragraph will be ascertained by the

Ministry, who will disclose the same through its official website.

(5) In time of procurements mentioned in the third and fourth paragraphs of this Article, the

entire responsibility for the retention of the products shall rest with the buyers of such

products.

(6) Warehouses may not sell or distribute the products covered by this Regulation to any

natural or legal persons, lacking possession of a license/authorization for selling or

distributing the same.

(7) (Insertion:OJ-11/1/2013-28525)(1) The following principles shall be complied with in

respect of sales, storage/retention and shipment of veterinary biological products.

a) (Amended:OJ-20/12/2014-29211) The marketing authorization holder and the veterinary

pharmaceutical warehouse may distribute any veterinary biological products only to the

veterinary pharmaceutical warehouses, animal hospitals holding retail sales authorization,

veterinary surgeon polyclinics and clinics, the public institutions authorized as per the third

paragraph and to the livestock enterprises authorized as per the fourth paragraph.

b) In order for being able to import its products, and to store and to distribute the same either

before and after the sales authorization, the holder of marketing authorization of the

veterinary biological product, imported or manufactured on subcontracting basis, should be a

veterinary or a representative pharmaceutical warehouse, or should have executed an

agreement with another veterinary or representative pharmaceutical warehouse for the storage

and shipment of the product.

c) The holder of the marketing authorization, the manufacturing site, the veterinary

pharmaceutical warehouse, sales point authorized for retail sales, and the livestock enterprises

authorized by the Ministry for supply of products, shall be obliged to ensure appropriate

storage and shipment temperatures, to monitor, to keep the records, and to provide any such

details when requested by the buyers, as per their responsibilities regarding importation of the

product, or storage, shipment from the manufacture and administration of the product.

ç) If the veterinary biological product is peculiar to use for diagnosis purposes, then the holder

of the marketing authorization or the veterinary pharmaceutical warehouse may distribute

such products to the diagnosis and analysis laboratories authorized by the Ministry, and to the

public organizations carrying out research and diagnosis activities in relation to animal

diseases.

d) At the livestock enterprises authorized by the Ministry, the veterinary biological products

may be administered only to the animals owned by that enterprise. The administration may be

implemented by the veterinary surgeons or assistant health-care personnel employed within

the organization of the enterprise.

e) Any integrated livestock enterprises, which have livestock and poultry at different

addresses, and which are authorized as per the fourth paragraph, shall obtain vehicles and

equipment appropriate for shipment of veterinary biological products. Such kind of livestock

enterprises shall employ veterinary surgeons and assistant health-care personnel at a number

sufficient to administration of the products, or shall have such administration performed at a

veterinary surgeon polyclinic, clinic or animal hospital situated at the location where the farm

or poultry house is situated. The products may not be stored at any places other than the ones,

for which an authorization is applied, and may not be delivered to farms, poultry houses and

the owners. The veterinary surgeon or the assistant health-care personnel, who has performed

such administration, shall issue an administration document, and shall deliver one copy of

such document to the owner of the farm or poultry house.

f) Any places authorized to perform retail sales may not sell and deliver any biological

products such as vaccines and serums and invivo test antigens to any livestock enterprises,

animal owners or breeders, and may not issue prescriptions for such products. The products

may be administered only by the veterinary surgeons or assistant health-care personnel at the

places that are authorized for retail sales. After the veterinary biological product is

administered, a document provided from the provincial directorate shall be issued, and a copy

of the relevant page shall be delivered to the owner of that animal.

g) Holders of marketing authorization, manufacturing sites, veterinary pharmaceutical

warehouses, places authorized to perform retail sales and the livestock enterprises authorized

as per the fourth paragraph shall add liquid nitrogen on the basis of regular time intervals to

the container of the products stored and kept in liquid nitrogen. Such places shall keep and

retain regularly the documents proving purchase of the liquid nitrogen they use, as well as the

records in relation to adding liquid nitrogen.

ğ) (Amended:OJ-20/12/2014-29211) In respect of the responsibility for monitoring of the

storage and shipment temperature and keeping the records thereof, of the marketing

authorization holders, manufacturing sites and veterinary pharmaceutical warehouses; such

responsibility shall cease upon delivery of the product to the other veterinary pharmaceutical

warehouses, retail sales points, the public institutions authorized as per the third paragraph or

the livestock enterprises authorized as per the fourth paragraph. The responsibility of the retail

sales points and the public institutions or livestock enterprises authorized for provision/supply

of products, shall start as of the time of delivery, and last to the administration of the product.

h) In the event that any livestock enterprise authorized as per the fourth paragraph fails to

fulfill the requirements and conditions regarding storage, shipment, administration and the

records of the veterinary biological products, or if such enterprise becomes deprived of the

same, or if such enterprise fails to monitor temperature during storage or shipment, then

provision/supply of such product shall be suspended until the situation is recovered. Such case

shall be notified to the veterinary pharmaceutical warehouses, that have performed the sales to

such enterprises, by the provincial directorate. In the event that either the entire or some

portion of the product, provided by the livestock enterprise, is administered by any other

persons than the veterinary surgeons or assistant health-care personnel, or if the records and

documents of the administration is not available, or is lacking, then the persons who have

carried out such administration shall be subjected to legal proceedings as per the sub-

paragraph (ç) of the first paragraph of Section 37 of the Law. If any livestock enterprise

distributes the product outside its organization, then such enterprise shall be subjected to legal

proceedings as per the sub-paragraph (g) of the first paragraph of Section 37 of the Law.

(8) (Insertion:OJ-20/12/2014-29211) The veterinary medical product manufacturing sites

and the research institutions and organizations may obtain products from the veterinary

pharmaceutical warehouses in respect of the research and development activities upon the

permission of the Ministry of Health.

Warehouse records

ARTICLE 42 – (1) Warehouses are obliged to keep all records of procurements, sales and

stocks of veterinary medical products, in such a manner that allows for traceability of these

products on the basis of production date, name, quantity, batch number, names and addresses

of persons or organizations from which products have been purchased or to which products

are distributed and for recall procedures when necessary, maintain all records and documents

up to-date and as ready for inspections for at least a period of five years, to submit the same to

the Ministry on demand and to make them available for reviews and inspections of inspectors.

(2) The warehouses should keep a Book of Supervisory Audits, to allow for putting on record

of various matters found during inspections.

(3) (Amended:OJ-20/12/2014-29211) Procedures and rules applicable to the records to be

kept and keeping of these records shall be ascertained through the instruction published by the

Ministry. The records shall be kept in respect of the psychotropic / narcotic products pursuant

to the legislation in relation to such products.

(4) (Amended:OJ-20/12/2014-29211) The veterinary pharmaceutical warehouse shall carry

out an internal audit at least once a year. Any non-conformities identified as a consequence of

the internal audit, and the reasons thereof, and any corrective and preventive actions taken

against such matter shall be recorded in detail, and such records shall be kept available for

audit for a period of five years.

(5) Delegated pharmaceutical warehouses should keep the entirety of records concerning the

products for which they carry out storage or secondary packaging services, according to the

provisions of this Article.

Branches and delegated pharmaceutical warehouses

ARTICLE 43 – (Amended:OJ-20/12/2014-29211)

(1) The veterinary pharmaceutical warehouses or branches/offices of the representative

veterinary pharmaceutical warehouses shall be obliged to obtain license.

(2) Any veterinary medical product manufacturing sites and any representative veterinary

pharmaceutical warehouses operating under the license issued by the Ministry of Health may

not perform distribution to the places other than the veterinary pharmaceutical warehouses

and the pharmaceutical warehouses operating under the license issued by the Ministry of

Health.

(3) The representative veterinary pharmaceutical warehouses may conduct the activities for

raw material, primary packaging, labeling, printed materials, storage, protection of reference

samples and auxiliary packaging, in respect of the manufacturing sites or the marketing

authorization holders, provided that they will satisfy the requirements of the good

manufacturing practices, and through an agreement executed by and between the parties. In

respect of the protection of products, the requirement of the veterinary pharmaceutical

warehouse shall be carried out.

Any changes in trade names and addresses of the representative veterinary

pharmaceutical warehouses and veterinary pharmaceutical warehouses, and transfers

thereof

ARTICLE 44 –(Amended along with the heading:OJ-20/12/2014-29211)

(1) If the warehouse changes its address to another location, the responsible manager shall

apply to the provincial directorate with an application letter, to which attached will be:

a) the approved development plan or occupancy permit of the address of relocation,

b) letter or other documentary form of consent of the board of directors of the legal person,

concerning relocation,

c) commercial registry paper indicating the new address after relocation,

ç) The layout plan drawn to a scale of 1/50, showing the equipment and various sections of

the new warehouse,

d) A certified document obtained from competent authorities to the effect that the location

reserved for use as a warehouse is suitable for the counts of fire safety.

e) receipt showing full payment of applicable fees and duties,

f) License and certification of responsible manager drawn for the former address,

(2) In case of any change in the address details of the warehouse, the owner of warehouse or

the responsible manager shall apply to the provincial directorate together with the new

address and the license to be revised, and the certificate of responsible manager.

(3) In case of any change in the trade name, the owner of the warehouse shall apply to the

provincial directorate together with the license to be revised and the certificate of responsible

manager, as well as with the Trade Registry Gazette stating the change of the trade name in

respect of the legal persons.

(4) If the warehouse is to be transferred, the transferee of the property shall apply for

registration with the provincial directorate together with the notary certified deed of transfer

entered by and between the transferor and the transferee and documents belonging to the

transferee as required for initial applications, the license to be revised, and the certificate of

responsible manager.

(5) In respect of change of place; in the event that application documents are found out to be

appropriate, the provincial directorate shall carry out on-site inspection, as in the first

application for license.

(6) In respect of transfer processes, the transfer of psychotropic/narcotic products shall be

carried out under the supervision of the authorities from the Ministry.

(7) The provincial directorate shall forward the applications that it deems appropriate, to the

Directorate General together with a copy of the application documents in order for issuance of

a new license.

Retail outlets and retail sales authorization

ARTICLE 45 – (Amended:OJ-11/1/2013-28525)(1)

(1) Retail sales authorization for veterinary medical products shall be issued in the name of

Ministry licensed clinics, polyclinics and the animal hospitals.

(2) Retail sales authorization for veterinary medical product shall be issued in the name of the

licensed veterinarian at clinics and polyclinics, or in the name of the practitioner of veterinary

medicine who will be designated as the person responsible for the sales of veterinary medical

products at clinics, polyclinics and animal hospitals opened up in the form of simple

partnerships.

(3) Applications will be filed with the provincial directorate, together with the following

documents:

a) The petition covering the Republic of Turkey ID Number and residence declaration and

telephone and fax numbers and the electronic mail address of the veterinary surgeon for

whose name a retail sales authorization will be issued.

b) A valid and up-to-date certificate of registration granted by the professional chamber, to

which the veterinary surgeon is registered, and list of signatures, and 4 passport photographs.

c) If the applicant is a legal person, the original or copy of the commercial registry excerpt

denoting the registered address of the company, its founding objectives, partnership structure

and people in charge of governance of the company, giving their respective duties, titles and

signature authority frames; and a copy of the articles of association of the company; and a

letter stating that a sales manager has been assigned.

ç) The receipt showing full payment of applicable fees and duties.

d) In respect of hospitals and any clinics and polyclinics, established by a veterinary surgeon,

if the sales manager is employed from outside of those places, then the labor contract stating

that such person is responsible for the activities and operations covered by the relevant

regulations; and the valid and up-to-date document stating that such person is insured and

working in accordance with the applicable legislation, obtained from the relevant public

entity.

e) The details pertaining to the vehicles used during shipment of veterinary medical products

to the farms or poultry houses for use of such products at the clinic services offered outside

the retail sales points, and the equipment used for transportation of the same.

(4) Provided that the consent of the clinic, polyclinic and the hospital is obtained, the

responsible persons may delegate a power of attorney to another veterinary surgeon, with

whom a service contract has been executed, in order for fulfillment of their duties in relation

to sales of the products. If the person, responsible for sales of the product, has delegates an

attorney at the workplace, then the documents pertaining to such attorney and regarding the

responsible manager as described within the third paragraph, and the deed of consent of the

attorney, shall be added to the application.

(5) The provincial directorate shall issue a report stating that all items, including facilities,

have been deemed appropriate upon completion of the on-site inspection, carried out on the

documents, within a period of fifteen business days. Such inspections shall be carried out by

two staff members. In respect of the sales points situated within the borders of the district, a

staff member serving at the district directorate shall attend the committee, and a copy of the

file shall be sent to the district directorate.

(6) ıf the sales point is not deemed appropriate upon completion of such inspection, then

information with the relevant grounds shall be delivered to the applicant within a period of

fifteen days. Should the applicant fails to remedy the defects and imperfections reported to it

within a period of one month after its receipt of notice on non-conformities, then the

application file shall be returned to the applicant.

(7) If the sales point is deemed appropriate, then a retail sales authorization for veterinary

medical product shall be issued within a period of fifteen days. Such document shall be issued

in two copies. One copy of the document shall be delivered to the concerned person. One

copy of the same shall be retained at the provincial directorate. If the sales point is situated

within the borders of the district, then a copy of the file shall also be delivered to the district

directorate.

(8) The retail sales authorization shall be arranged in the name of a veterinarian. No further

authorizations can be granted to this person.

(9) If the sales manager resigns active office for any reason whatsoever, then the clinic,

polyclinic or hospital shall be obliged to designate a new sales manager within five business

days, at the latest; and to submit an application to the provincial directorate with the previous

sales authorization. Within this period, the veterinarian reported as substitute will carry out

such procedures and transactions concerning sales. If no sales manager is appointed on time,

then the authorization shall be revoked, and sales activity shall be ceased; and the products

shall be seized until a new manager is appointed.

Relocation, transfer and closure procedures

ARTICLE 46 – (Amended along with the heading:OJ-20/12/2014-29211)

(1) The holder of retail sales authorization shall apply to the provincial directorate together

with a properly arranged letter of application and the previously granted authorization as well

as full set of documents sought for obtaining of the authorization, for the new address he plans

to relocate his business and assets. As in the case for initial applications, the new

authorization shall be granted if the application is found eligible, at the end of inspections

duly performed. If the relocation process is to be carried out within the borders of different

provinces, then the letter of transfer of the provincial directorate granting the previous retail

sale authorization and the details for the stock products during the transfer process shall be

attached to the application documents.

(2) If the ownership and control of the clinic, polyclinic or animal hospital is transferred to a

third party, the retail sales authorization will immediately become null and void. The persons

taking over the property of the sales point as transferee shall apply to the provincial

directorate for obtaining a new retail sales authorization on their behalf, through an

application letter and the previously granted authorization provided in the attachment thereof.

(3) In case of transfer or closure of the workplace, the retail sales authorization holder or

his/her legal successors in case of his death, shall apply to the provincial directorate granting

the authorization together with an application letter. The provincial directorate shall carry out

on-site inspection in relation to the application within a period of 15 days. Book of

Supervisory Audits, Book of Narcotics and Psychotropic Product Inventory and Consumables

and any other books shall be received by the provincial directorate through the an official

report in order to be retained, and shall be delivered to its authorization holder in order to be

retained for the period of other records.

(4) The products available in the stock shall be identified through the official report, and shall

be delivered to the authorization holder in order to be transferred to any other retail sales

point, or to the point from which it has been purchased. Upon the request or in case of

expiration of their shelf lives, such products shall be disposed of. Such processes shall be

carried out within the permission and knowledge of the provincial directorate. Any products,

which are not transferred or returned within a period of six months, shall be disposed of at the

cost of its owner.

(5) The authorization holder shall provide any records for the retention conditions of the

products to be transferred or returned.

(6) In respect of the transfer and closure processes, no retail sales authorization shall be issued

to the retail sales authorization holder, which fails to carry put his/her responsibility

prescribed under this Regulation, for a period of two years.

Records of retail outlets

ARTICLE 47 – (1) Retail outlets possessing valid sales authorizations should keep and

maintain the following books:

a) a Book of Supervisory Audits in which facts and matters established in time of audits will

be entered,

b) A Veterinary Medical Product Register, where each incoming veterinary medical product

shall be entered, upon arrival at the retail outlet,

c) (Abrogated:OJ-11/1/2013-28525)(1)

ç) Book of Narcotics and Psychotropic Product Inventory and Consumables,

d) A Returned/Reassigned Goods Registry, in which veterinary medical products that have

been rejected or transferred, for which a decision of recall was taken.

(2) (Amended:OJ-11/1/2013-28525)(1) At the retail outlets, prescription sales may be

performed as described below:

a) In respect of any sales as performed by relying on the prescription of the veterinary surgeon

outside the retail outlet, the incoming prescription shall be kept at a separate file basing on the

date of incoming.

b) The veterinary surgeons of the retail outlets shall issue a prescription for the veterinary

medical products they use for treatment and the examination they performed. The details

regarding such prescriptions shall be recorded on to the recording book of the outlet; and the

prescription shall be kept at a separate file basing on the date of the prescription.

c) The veterinary surgeons of the outlet may issue prescriptions, without performing any

examinations, for recommendation purposes, to the owners of the animals, at the cases other

than the situations described in the sub-paragraphs (a) and (b). If the recommended veterinary

medical products are delivered to the owners of the animals by the outlet, then such

prescriptions shall be kept at a file separate from the other prescriptions, basing on the date

order.

(3) (Amended:OJ-11/1/2013-28525)(1) In respect of all prescriptions, the retention period

shall be at least five years, unless otherwise is not indicated by the Ministry. The prescription

groups indicated in the second paragraph shall be retained separate from each other.

Prescriptions are deemed as the record of the products exited from the outlet.

(4) The commercial documents relevant to purchase, sale, transfer and return procedures shall

be kept in separate files for at least a period of two years, in order of chronology.

(5) Prescriptions of Narcotics and Psychotropic Drugs and all commercial documents shall be

retained in separate folders from those containing the files of other veterinary medical

products, for at least a period of five years.

(6) Registry and record entries should be easily readable and conceivable, facilitating for easy

and fast access and kept in such a way to allow backward tracking of all related activities and

stages, for at least a period of five years.

(7) All books and registers except Book of Supervisory Audits and Book of Narcotics and

Psychotropic Product Inventory and Consumables may be kept on electronic storages in such

form as designated by the people responsible for the same, save that they contain all the

required information. This will not affect the retention times of records, the ultimate

responsibility of which rests with the sales authorization holder.

(8) At least once a year a detailed audit shall be carried out to compare incoming and outgoing

medical supplies with supplies currently held in stock, any discrepancies being recorded.

These records shall be available for inspection by the competent authorities for a period of at

least five years.

(9) Procedures and rules applicable to the records to be kept and keeping of these records will

be ascertained by the Ministry, who will disclose the same through its official website.

(10) (Insertion:OJ-11/1/2013-28525)(1) In case of promulgation of a monitoring system, the

Ministry may perform changes in respect of the records and books to be kept by the retail

outlets.

(11) (Insertion:OJ-11/1/2013-28525)(1) The pharmacies may sell any products subject to

prescription in accordance with the sub-paragraph (a) of the second paragraph.

Rules Pertaining to Prescriptions

ARTICLE 48 – (1) The veterinarian who administers or recommends administration of any

given veterinary medical product to an animal should arrange a prescription for the purpose of

documenting the situation, when required, and hand such prescription to the person taking

care of the animal, putting it on record, if necessary.

(2) The veterinarian’s prescription should at least contain a date, personal identity particulars

of the veterinarians (i.e. name and surname, signature, address, reference number of diploma

or other certificate of formal qualification held etc.), identification information of the animal

and information on the veterinary medical product or preparation prescribed (name, strength

and pharmaceutical form, indications of use, commercial presentation form, route of

administration, doses and treatment period).

(3) The Ministry may introduce special arrangements in the informative content of

prescriptions and use thereof for a particular situation, enterprise, class or category of

veterinary medical products or group of animals and render the application thereof mandatory

or may categorize prescriptions. The products’ status of being subject to prescription will be

ascertained by the Ministry, who will disclose the same through its official website.

(4) The veterinarian may use authorized veterinary medical products other than biological

veterinary medical products off-label or recommend such practice, if there is not any

preferable or advisable authorized veterinary medical product available for use in a particular

case of treatment. In such case, the veterinarian will be obliged to give all necessary

information to the breeder or ranch owner concerning any and all potential effects and

consequences of the off-label use and indicate it in appropriate records and on the prescription

clearly. In case of off-label use, if not a specific withdrawal period has been ascertained for

the veterinary medical product in use depending on relevant animal species, the Ministry may

introduce a minimum time-limit and/or set of rules. The responsibility associated with off-

label use shall rest with the administrator and acceptor of the administration of the veterinary

medical product.

(5) No further entries of another veterinary medical product can be made on the prescriptions

containing information about psychotropic and narcotic products.

(6) Prescriptions shall be drawn in at least three copies. One copy shall be retained by the

prescribing veterinarian. The remaining two copies will be entrusted to the animal owner for

with one original to be finally delivery at the retail outlet of the veterinary medical product. If

the prescribed veterinary medical product is a medicated veterinary premix, then prescription

shall be arranged in four originals and the fourth copy will be retained at the premise to

prepare the medicated feeding stuff.

(7) (Insertion:OJ-11/1/2013-28525)(1) The animal owners shall retain any invoices,

prescriptions and records in relation to any medical products administered to their animals,

including those administered previously before the purchasing, even if the animals have been

sacrificed, the animal or the product of the same has been consumed as a foodstuff, at least for

a period of five years. Such records shall be kept so as to cover the details such as the name of

the product, its pharmaceutical form, administration route, date and amount, any off-label

administration, if any, and any details thereto, the date of provision/supply of the product, and

the address of such provision/supply, and so as to avoid any doubt in terms of the animals

treated. The animal owners shall be obliged to present such records to the Ministry, when and

if requested. The Ministry shall determine the principles in relation to the records, which are

required to be kept by the animal owners or the livestock enterprises; and shall announce such

principles on its official website.

Rules Pertaining to Retail Trades

ARTICLE 49 – (1) Below set are the rules and principles that must be followed in time of

retail trading of veterinary medical products::

a) Trading transactions may not be carried out by such means as explicitly not permitted by

the Ministry.

b) Sale transactions will be performed under responsibility and supervision of the veterinarian

to whom a retail sales authorization has been granted or his duly authorized assign. No one

but these people may finalise the sale.

c) Veterinary medical products sold on prescriptions may not be sold without the same.

ç) Prescriptions not arranged properly according to established produce or having lost the

quality of being an official document and prescriptions sent via the Internet, facsimile or

phone communications, couriers, brokers or other similar means shall not be acceptable. The

provisions of this paragraph shall not apply to electronically made prescriptions (e-

prescriptions) obtaining physical form and effect immediately after being prepared on

electronic environment and digitally signed in a secure way by the prescribing veterinarian.

d) Psychotropic and narcotic products may be sold and delivered only to the veterinarian who

has made the prescription. They may not be sold or delivered to any other person. (Amended

last sentence:OJ-11/1/2013-28525)(1) The details shall be recorded into the product registry

logbook, as well as the Book of Narcotics and Psychotropic Product Inventory and

Consumables.

e) Separate billing shall be made for psychotropic and narcotic medical preparations, a copy

of which shall be retained for at least a period of five years.

f) Peddling on portable benches or booths and sale of veterinary medical products in circuits

are hereby prohibited. The delivery of veterinary medical products in use to the owner or

caregiver of the treated animal in time of examination or intervention shall be an exception to

this rule.

g) Retail outlets may neither trade veterinary medical products among themselves inter alia,

nor sell the same to warehouses. However, in cases of emergency, where the sale or use of

veterinary medical products are restricted by a revocation of sales authorization or the

activities of the manufacturer or distributor thereof are to be suspended for a long period of

time, due to a medical or legal urgency, sales can be performed with a view to ensure transfer

and assignment of the veterinary medical products, under direct supervision of officials from

the provincial or district directorate, when this becomes necessary. The outlets may return

excess veterinary medical products back to the warehouses from which they purchased the

same in the first place.

ğ) The retail outlets may, in no way, perform wholesale dealings or sign up for and participate

in procurement sessions to be staged for the purpose.

h) The veterinary medical products that have to be administered only by a veterinarian or

assistant health personnel may be sold only to the same.

CHAPTER FIVE

Promotion of Veterinary Medical Products

Scope of Promotions

ARTICLE 50 – (1) The promotion of veterinary medical products for which a marketing

authorization has been granted may be carried out by marketing authorization holders or

people to whom the latter has delegated their powers in such capacity. No entity, organization,

association, society, foundation, union or other similar body or undertaking but the marketing

authorization holder may promote, recommend or encourage the use of veterinary medical

products, even through the veterinarian. No veterinary medical product can be promoted

publicly, in the absence of a valid marketing authorization.

(2) (Amended:OJ-11/1/2013-28525)(1) Promotional activities cover the promotion of the

products, covered by this Regulation, to the veterinary surgeons and pharmacists, and

providing information about administration and side/adverse effects of those products to the

other health-care professionals. The promotion oriented at health-care professionals shall be

carried out by means of professional media, supporting of or arranging scientific activities, or

organizing visits to such professionals by the promotion representatives.

(3) (Amended:OJ-11/1/2013-28525)(1) Only the products, allowed to be sold to such

workplaces, may be promoted to the workplaces selling homing pigeons and aquarium fish

and exotic decoration animals under license issued by the Ministry.

(4) (Amended first sentence:OJ-11/1/2013-28525)(1) The products cannot be advertised or

promoted through mass communication means and media such as radio, television,

newspapers, magazines, and the Internet and etc. However, with the exception of veterinary

medical products with recognized narcotic and psychotropic effects, disclosures can be made

with respect to a veterinary medical product on newspapers and magazines, which reports that

the veterinary medical product in question has been placed on the market under the heading

“To the attention of veterinarians and pharmacists” and communicates the name or title or

distinguishing emblem or other insignia of the authorization holder, the commercial name of

the product, strength and pharmaceutical form, the generic names of its active ingredients, the

brief indication of pharmacotherapeutic use, date and number of authorization granted and

whether or not it is available on prescription. The contract address of the marketing

authorization holder may as well be included, if deemed necessary or desirable. These

disclosures will not contain any pictures other than those of the veterinary medical product.

The approval of the Ministry must be sought and obtained for disclosures of this type,

wherefore, the final texts to be disclosed should be sent to the Ministry at a suitably prior

time. Press releases can be published only for once. Press releases to be published on

newspapers may not exceed 1/8 of the full page size, in dimensions.

(5) (Amended:OJ-11/1/2013-28525)(1) Only the publications delivered or sold to the

veterinary surgeons and pharmacists, and the publications containing scientific and medical

texts shall be accepted as professional media. The press and media delivering news targeted at

breeders shall not be deemed as professional media.

(6) The wholesalers and retail outlets of veterinary medical products may not disclose or

announce that they are engaged in the sales thereof, neither can they carry out any

promotional efforts concerning the products. No such materials as posters, notices and etc.

that promote the veterinary medical products may be hung or juxtaposed in sales premises

except those bearing the phrase “please consult a veterinarian for name of the product”.

(7) Veterinary medical products with recognized narcotic and psychotropic effects may not be

promoted through informative or reminding efforts, by means of means of mass

communication or diluted samples or prototypes of them may not be prepared and distributed.

These products may only be promoted in the professional media.

(8) Promotional arguments employing comparative approaches and methods should coincide

with scientific facts and professional ethics and be demonstrable. Promotional arguments

should not target a specific competitive product.

(9) (Amended:OJ-20/12/2014-29211) No promotional or advertising material may be

included in product labeling or leaflet, excluding the special uses thereof.

(10) (Amended:OJ-11/1/2013-28525)(1) The marketing authorization holders may issue

summary of product characteristics or leaflets on their websites. As an exception to the fourth

paragraph, the marketing authorization holders, which wish to carry out advertisement and

promotion in relation to their products through the Internet, shall establish domains that can

be accessed only by means of personal passwords, etc., and that are prepared as oriented to

the veterinarians and pharmacists.

(11) (Insertion:OJ-20/12/2014-29211) The promotional works for the veterinary medical

products shall be conducted in line with the provisions of the guidance published according to

this Regulation.

General characteristics of promotional information

ARTICLE 51 – (1) All information supplied in promotional materials of a veterinary medical

product should absolutely be true, realistic, provable, valid and reliable. These information

may not and shall not be arranged or handed out in such a manner that would cause

unnecessary or excessive use or detrimental effects of the veterinary product. The information

provided should be consistent with those provided in the package insert or leaflet.

(2) Since no particular medicament is safe in an absolute sense, use of the term “safe” should

be avoided in a promotional material, unless and until the relevant criteria and class are given.

(3) Citations to be made in promotional materials shall be incorporated into the context

thereof, with full reference made to their bibliographical sources.

(4) Information should be covered on potentially hazardous or detrimental impacts to human,

animal and environmental health of the veterinary medical products.

Representative

ARTICLE 52 – (1) The promoting representative should have full knowledge of scientific

data and facts, as and to the extent required for the successful promotion of the veterinary

medical product. The qualifications of the representatives shall be at responsibility of the

product authorization holders. For such purpose, the product authorization holders should give

the necessary training to representatives.

(2) The representative should report any adverse information concerning the veterinary

medical products he is promoting, to the product authorization holder.

(3) The product authorization holder shall be responsible for all promotional activities to be

conducted by the representatives, as well as all matters regarded with the promotion.

(4) (Insertion:OJ-20/12/2014-29211) The qualifications of the promotion representatives,

working procedures and principles thereof, and all practices in relation to such matter shall be

determined in line with the instruction published by the Directorate General.

Representative Samples

ARTICLE 53 – (1) The veterinary medical product samples to be used for promotional

purposes shall meet the following requirements:

a) No price statements should be included.

b) Samples should be presented in reduced quantities from the smallest commercial

presentation form of product placed on the market. However, the promotional samples of

veterinary medical products the quantities of which may not be reduced due to their

pharmaceutical form may be used as is.

c) The wording “specimen for veterinary use only, not for sale” should be placed on both

immediate and outer packaging labels in an appealing manner.

ç) The sample may not be differ from the original product except for characteristics specified

in this paragraph.

(2) Samples of veterinary medical products available on prescription can only be given to

veterinarians.

(3) Authorization holders will set up a satisfactory recording and control system for the

manufacturing, importation and dispensing of free representative product samples, identifying

persons to assume responsibilities thereof. These records shall be reported to the authorized

representatives of the Ministry whether by electronic means or in printed hard copies in such

form and content to be designated by the Ministry, upon request.

(4) The annual distribution quantities of free representative samples may not exceed 5% of the

volume of sales realized in the preceding year, with the product they relate. The sample

distribution activities shall be limited to two years from the date on which the veterinary

medical product is placed on the market.

(5) Promotional samples may not be used as research material in clinical studies.

Promotional materials and promotions

ARTICLE 54 – (1) The promotional materials should at least meet the following

characteristic requirements:

a) Promotional materials shall be dispensable only to veterinarians and pharmacists. However,

the Ministry may exclude the promotional materials intended for use as product reminders so

as to include the commercial names and names and logos of authorization holders of

veterinary medical products that do not leave residues in food-producing animals or require

specialized knowledge and experience for being used, from operation of this clause.

b) The materials should not go beyond their intended purpose as product reminders both

qualitatively and quantitatively, but remain within modest limits in material value. The

Ministry shall set the maximum material value of the promotional materials, when necessary.

c) The entire information provided on package inserts or leaflets of veterinary medical

product should be used in such materials as books, booklets, brochures, slides, films and etc.,

which contain more than information supplied on the name, strength, pharmaceutical form

and authorization holder of the veterinary medical product.

(2) (Amended:OJ-11/1/2013-28525)(1) No gifts, promotional distributions, lotteries or draws,

special offers and campaigns other than price discounts will be permitted for encouraging use

and boost up sales of the veterinary medical products; and no direct or indirect material gains

shall be allowed begotten from people who intend to use or prescribe for the same. However,

professional materials may be handed over to veterinarians or pharmacists, provided that other

requirements are successfully met..

(3) Product or sample donations made in courtesy to public entities and organizations and

other persons, bodies and establishments approved by the Ministry for supporting scientific

research and education shall be excluded from coverage.

(4) Marketing authorization holders may distribute posters or promotional materials

containing informative and awareness-raising statements on concerns of human, animal and

environmental health, in addition to corporate logos to all societal segments, save on

condition that they mark a target community group in the first place and avoid advertising the

veterinary medical products.

Activities and liability

ARTICLE 55 – (1) The veterinarian, holders of the marketing authorization for a medical

product for veterinary use or any authorized agents or permitted assigns thereof may organize

and hold or sponsor and/or support such events as meetings, seminars, symposium,

educational gatherings and etc. or take part in such events as expositions, concerning the

veterinary medical products in their possession. The Ministry may appoint observers to these

events.

(2) Hospitalization of guests during these activities should always be kept at a reasonable

level and assigned to second degree in priority of concern, given the main intentions with the

gathering and should be delivered only to veterinary surgeons and pharmacists, excluding VIP

guests.

(3) No activity other than those clearly specified under this Article shall be permitted

conducted for the purpose of promoting a particular veterinary medical product.

(4) The holders of authorization shall be liable for:

a) ensuring that the promotional activity with regard to a veterinary medical product for which

an authorization has been granted is conducted in strict compliance with the requirements of

this Regulation.

b) providing any and all information and documents concerning the promotional activities, if

required by the Ministry.

c) saving and keeping one each copy of all promotional materials to be used for a period of

two years, for resubmission to the Ministry, if and when requested.

ç) ensuring, mediating and being instrumental to implementation of all decisions taken by the

Ministry on promotions of veterinary medical products.

d) conveying all such documents as relevant to the promotional activities whether already

conducted or to be conducted in future and arranging for and ensuring the training of

representatives on legal and scientific subjects, upon request.

CHAPTER SIX

Pharmacovigilance

Pharmacovigilance activities

ARTICLE 56 – (1) The pharmacovigilance activities shall be conducted by all related parties

using such information as derived or obtained from the following references:

a) reports and manifests of veterinarians or pharmacists,

b) Post-authorisation safety studies, including pharmaco-epidemiological studies,

c) decisions adopted by competent authorities of other countries on efficacy and safety of

products,

ç) national and international scholarly articles on efficacy and reliability,

d) other information that may affect assessment of benefits or risks of the veterinary medical

product such as non-conforming use or misuse of the product,

e) data that may provide additional information on efficacy and reliability of any given

product and on other signals of risk,

f) Computerized health databases,

g) Feedbacks and complaints from breeders and administrators,

ğ) results obtained from supervisory audits or tests performed on field samples.

Obligations of the authorization holders

ARTICLE 57 – (1) Since guaranteeing the efficacy and safety of veterinary medical product

is the first and foremost responsibility of him, the authorization holder shall be obliged to take

all precautionary and other measures as necessary for ensuring continuous monitoring with

efficiency of pharmacovigilance efforts, establishment and subsequently, sustenance of the

necessary system of pharmacovigilance, including but not limited to training his own in-house

staff.

(2) The authorization holder will secure continued participation of the person who he has

appointed to be his pharmacovigilance manager in training courses on pharmacovigilance

either organised or approved by the Ministry.

(3) The authorization holder has to recruit and employ a pharmacovigilance manager on a

perpetual basis, within his organisation, even if he carries out pharmacovigilance activities

through any other commercial, academic or scientific enterprise.

(4) The holder of authorization shall be liable, with regard to information reaching at their

hands, for:

a) comprehensive record-keeping and archiving on all suspected adverse reactions taking

place in Turkey or any other country in which the veterinary medical product in question is

being marketed.

b) recording and reporting all suspected serious adverse reactions and human adverse

reactions related to the use of veterinary medical products, of which he can reasonably be

expected to have knowledge, or which are brought to his attention, immediately to the

Ministry, and in no case later than fifteen days following the receipt of the information.

c) recording and immediately reporting all other suspected serious adverse reactions, which

meet all reporting criteria pursuant to the guidelines on pharmacovigilance and of which he

can reasonably be expected to have knowledge, or which are brought to his attention,

immediately to the Ministry, and in any case, no later than fifteen days following the receipt

of the information.

ç) ensuring that incidents of suspected adverse reactions and human adverse reactions,

altering the known risk-benefit balance of the product and anyhow occurring in the territory

of another country, which are brought to his attention are reported collectively and without

delay, so that they are available to the Ministry and in no case later than fifteen days

following the receipt of the information.

d) reporting all undesirable effects or adverse reactions not of a serious or unexpected nature,

only inside the periodic safety update report and at such times as mentioned in paragraph (e)

of this article or in a collated batch to the Ministry, on its request.

e) submitting records of all adverse reactions to the Ministry in the form of a periodic safety

update report, either immediately upon request or periodically as follows: six monthly for the

first two years after authorization, annually for the subsequent two years, and at the same time

of the first renewal. Thereafter, the periodic safety update reports shall be submitted at five-

yearly intervals together with the application for renewal of the authorization. The periodic

safety update report shall include a scientific evaluation of the benefits and risks afforded by

the veterinary medical product.

Pharmacovigilance manager and competent pharmacovigilance service institution

ARTICLE 58 – (Amended along with the heading:OJ-20/12/2014-29211)

(1) The pharmacovigilance manager shall be responsible for the following;

a) the establishment and maintenance of a system which ensures that information about all

suspected adverse reactions which are reported to the personnel of the company, including its

representatives, is collected and collated in order to be accessible at least at one point within

the country;

b) collection, recording, archiving and evaluation of information concerning risks and

reliability afforded by veterinary medical products and in this context, ensuring full

availability of up-to-date information in marketing authorization files of the products;

c) ensuring that any request from the competent authorities for the provision of additional

information necessary for the evaluation of the benefits and risks afforded by a veterinary

medical product is answered fully and promptly, including the provision of information about

the volume of sales or prescriptions of the veterinary medical product concerned;

ç) ensuring cooperation and coordination with the Ministry at necessary levels;

d) the provision to the Ministry in a timely and prompt manner, of any other information

relevant to the evaluation of the benefits and risks afforded by a veterinary medical product,

including appropriate information on post-marketing surveillance studies;

e) monitoring, checking and auditing the activities of the competent pharmacovigilance

institution in case of procurement of pharmacovigilance service, and reporting any

nonconformities to the Ministry.

(2) That qualified person responsible for pharmacovigilance and the competent

pharmacovigilance service institution shall conduct all his activities in line with the guidance

published according to this Regulation.

(3) The responsibilities of the pharmacovigilance service institution are as follows;

a) To establish and operate a system which will enable to provide pharmacovigilance service,

b) To monitor and assess all suspected adverse effects which are reported directly or

indirectly to the institution by the Ministry, marketing authorization holders or

representatives, health care professionals or owners of animals, provided that such effects are

related to the products in respect of which pharmacovigilance service is provided,

c) To collect, record, archive and evaluate any information concerning risks and reliability of

the products, pharmacovigilance studies of which are monitored by it, and to submit such

information to the marketing authorization holder,

ç) To submit any information and documents in relation to the periodical reliability updating

report and reliability studies upon granting of authorization of the products,

pharmacovigilance studies of which are monitored by it, to the Ministry,

d) To carry out the obligations of the marketing authorization holder against the Ministry,

e) To ensure the collaboration and coordination between the marketing authorization holder

and the Ministry.

Obligations of healt-hcare professionals

ARTICLE 59 – (1) The health-care professionals will professionally be obliged to report any

adverse reactions occurring in relation to the use of veterinary medical product in patients,

which they personally witness, to the Ministry.

(2) The health-care professionals shall report the serious and unexpected adverse reactions

which occur in relation to the use of veterinary medical product in their clinical attendance

and which may reasonably be linked to the product, to the Ministry either directly or through

the provincial/district directorates at which they assume roles and in no case later than fifteen

days following the receipt of the information.

Confidentiality

ARTICLE 60 – (1) The identities and resident addresses of the animal owners and reporting

health-care professionals shall be kept confidential in reporting made to the Ministry, by the

Ministry. Such information may never be divulged to any persons other than the resident

personnel of the Ministry without express consents of the people to which they appertain. The

authorization holders, health-care institutions and organizations and health-care professionals

shall be abided by and strictly follow the same confidentiality requirements.

(2) (Insertion:OJ-20/12/2014-29211) The competent pharmacovigilance service institution

may not disclose any information on the source and content of the notification served to it in

respect of the product, the studies of which are conducted by the same, in any manner

whatsoever, to any institutions or persons other than the marketing authorization holder and

the Ministry.

Report forms

ARTICLE 61 – (1) The adverse reaction reporting form shall be used for reporting of adverse

reactions of authorized veterinary medical products to the Ministry. In cases where no such

form is available, reporting shall be done in freestyle writing. Details regarding the reports

shall be provided in the guidance published according to this Regulation.

Ministry’s Obligation To Report

ARTICLE 62 – (1) The ministry shall report any suspected serious adverse reactions of a

veterinary medical product, occurring within the territory of Turkey, which are brought to its

attention through statutory reporting, to the related marketing authorization holder in no later

than fifteen days following the receipt of the information. The Ministry may share and

exchange information with international organizations having continued interest in the area,

with which it has established contacts.

Assessment by the Ministry

ARTICLE 63 – (1) The feedback, information and reports reaching at the Ministry

concerning pharmacovigilance activities, including the post-authorization reliability studies,

will be assessed and evaluated by the Committee for Medical Products for Veterinary Use.

The Ministry shall carry out the communications it is expected to carry out in relation to

matters it considers as needing change in the safety information of veterinary medical

products and other necessary notifications as regards its decisions for or against recalls,

suspensions or revocations within fifteen calendar days following the committee’s completing

its assessment. In case of urgency, the Ministry may suspend the marketing authorization of a

veterinary medical product, provided the marketing authorization holder is informed at the

latest on the following working day.

Products without marketing authorization

ARTICLE 64 – (Amended along with the heading:OJ-11/1/2013-28525)(1)

(1) Monitoring of any feedback received from health-care professionals in relation to the

adverse effects of the autovaccines and the products, which are not authorized in Turkey, but

which are authorized to be imported, manufactured or used, shall be carried out in accordance

with the provisions of this Regulation.

Reconsideration

ARTICLE 65 – (Amended:OJ-11/1/2013-28525)(1)

(1) The Ministry may request a reconsideration of the products for which a marketing

authorization has been granted, and for that purpose, it may demand additional information

and documents. At the end of the reconsideration, it may revoke or suspend the marketing

authorization granted for product, or alter or amend the terms applicable to manufacturing,

importation, sales, supply and use thereof, and grant any extra time as reasonably needed for

the alternations or amendments to be made and gain effect.

(2) With reservation of the provisions of fourth paragraph, the time for expiry of marketing

authorizations shall be five years. The marketing authorizations may be renewed at the end of

this five-years period, based on an assessment of the risks against benefits analysis. The

marketing authorization holder shall submit his application to the Directorate General

incorporating his claim for extension, accompanied by the list of documentation on quality,

safety and efficacy and the original copy of the authorization, until six months prior to formal

expiry of his marketing authorization. The Directorate General will be entitled to inquire this

information from the authorization holder, at any time. (Amended sentence:OJ-20/12/2014-

29211) For the renewal of marketing authorizations granted for products authorized abroad,

the administrative documents specified in Article 8 hereof should also be provided in the

attachment of the application.

(3) Once renewed, a marketing authorization will gain validity for an unlimited period of

time, if not a further request for its renewal is moved at the end of the next five-years period,

within the framework of pharmacovigilance efforts pursued by the Directorate

General. (Amended sentence:OJ-20/12/2014-29211) Renewal of marketing authorizations,

granted for any product, for an indefinite period of time shall not relieve the authorization

holder from any liabilities or obligations.

(4) The authorizations granted for veterinary medical products which are not placed on the

market within three years after the receipt of marketing authorization or following latest

placement of the veterinary medical product on the market shall be revoked.

(5) The Directorate General may bring exceptions to the fourth paragraph, in cases of

requirement and provided that it has fully justifiable reasons, for protecting the health of

animals or human beings.

(6) (Amended:OJ-20/12/2014-29211) The authorization of the products, application of

which has not been submitted upon expiration of its validity period, or deficiencies of which

have not been eliminated, shall be deemed to have been suspended as of the mentioned date.

The authorizations originally granted for the products, for which not any claims are raised for

a renewal through applications or raised but with defects and imperfections, which are not

remedied within a period six months following expiry of validities, shall be revoked.

However, the Ministry may grant an additional extension of three months, after considering

the period of delay in submission of documents required in respect of the products authorized

abroad.

CHAPTER SEVEN

Product recall

Preamble with recalls

ARTICLE 66 – (1) Product recalls are implemented with a view to prevent effective

distribution and/or use of a veterinary medical product reported to be defective, in order to

ensure availability of defect-free, high quality products in the market, while protecting the

health and safety of the consumer.

(2) Recall shall be initiated either on request of the Ministry or manufacturer’s resolve. The

recall procedure will be carried out by the company responsible for the veterinary medical

products, under supervision of the Ministry. The company responsible for the veterinary

medical products is liable for acting in good faith and upon principles of accountability,

taking all measures as may reasonably be found necessary by the Ministry in relation to the

recall operation.

(3) (Insertion:OJ-20/12/2014-29211) Any defective products, in respect of which the person

responsible for the defect cannot be identified, shall be recalled by the Ministry. The decision

on the products recalled shall be made by the Ministry. In case of identification of it, any

expenses incurred for such recall shall be collected from the person responsible for it.

Obligations of the marketing authorization holders with regard to product recalls

ARTICLE 67 – (1) Regarding the recall operation(Amended expression:OJ-11/1/2013-

28525)(1) the marketing authorization holders will be obliged to fulfill the following

requirements;

a) Distribution records should be arranged so as to ensure recognition of every batch and

every customer and product recall within the shortest possible time, when required.

b) A product recovery plan shall be drawn allowing fast and effective product recall, which

may be put under implementation immediately, at any time. This plan will describe the

various roles and responsibilities, paths to be followed, places where notifications are to be

made and information given, manner of notifications and procedures for the record-keeping in

relation to the returning veterinary medical products, as separate for each recovery operation.

c) A system will be established, which will be capable of transferring the required information

and instruction in a short time to the depths of the levels that the product recall will penetrate.

ç) In circumstances where lives are threatened, the responsible company shall inform the

Ministry immediately and without having regard to the day of the week or time of the day.

d) Modifications and attachments made to the recall plan shall also be notified to the Ministry.

e) The responsible company will be liable for indemnifying those affected by the recall to the

level and extent the procedure reaches at. The path to be followed on this matter shall be

established and indicated by the responsible company in the notification. The responsible

company will be obliged to fulfill this procedure in such a period of time as needed to not put

people and entities from which products were recalled, at unease. However, such period may

not be greater than two months.

f) (Insertion:OJ-20/12/2014-29211) In the event that the marketing authorization holder fails

to carry out her/his responsibility for recalling process, then such process shall be carried out

by the Ministry. All expenses incurred for such process shall be collected from the marketing

authorization holder.

Classification of Recalls

ARTICLE 68 – (1) This Regulation categorizes all recalls into one of three classes, according

to the level of hazard involved, as follows:

a) Class I: Dangerous or defective products that predictably could cause serious health

problems or death,

b) Class II: Products that might cause a temporary and curable health problem, or pose only a

slight threat of a serious nature, (Amended expression:OJ-20/12/2014-29211) and

ineffectiveness and effectiveness decreases,

c) Class III: Products that are unlikely to cause any adverse health reaction.

(2) Recalls fall within either one of the following type designations, depending on how deep

they need to extend, in the distribution chain.

a) A type A recall is designed to reach individual customers or patients through media release

(radio, television, regional and national press), and Class I recalls generally fall within this

type designation.

b) A type B recall is designed to reach wholesalers throughout the country, directors of

hospital services (private as well as state hospitals), Ministry approved retail outlets, doctors,

nurses, pharmacists, authorized prescribers and dispensers. Class II recalls generally fall

within this type designation.

c) A type C recall is designed to reach wholesale level and other distribution points (e.g.

pharmacies, doctors, hospitals). Class III recalls generally fall within this type designation.

Reasons of Recalls

ARTICLE 69 – (1) Defects associated with the quality of the products, lacks or omissions in

good manufacturing practices and labeling errors are among the main reasons for product

recalls. A recall will be implemented, when the requirement arises, due to:

a) Defects related with product packaging, such as leaks, damage, material deformation,

manufacturing fault, use of non-compliant packaging etc.

b) Labeling and printing errors such as mislabeling - wrong or missing text or figures,

Missing or incorrect information - leaflets or inserts and etc.

c) Defects relating to content, such as Contamination, for example, microbial spoilage, dirt or

detritus, particulate matter, Chemical/physical contamination (significant impurities, cross-

contamination, particulates), presence of pyrogens, chemical decomposition, deformation in

aesthetics, form and taste, collapses, turbidity, ambiguous substances, deviations from

specified standards and etc.

ç) Defects relating to efficacy of the product such as ineffective product, serious adverse

reactions and toxicity etc.

d) Such other reasons as unauthorized production, unauthorized changes in formulation,

packaging and manufacturing site of products, expired products, non-compliance with good

manufacturing practices and etc.

Recall procedures

ARTICLE 70 – (1) If anything comes up rendering a product recall necessary, the Ministry

will inform the responsible company, asking it to start with recall procedure. The Ministry

shall state the level of depth and class of the recall in their notification.

(2) Having commenced with the recall procedure, the company will furnish the Ministry with

such information as referred to under third paragraph of this Article concerning the product

being recalled. It will be incumbent upon the responsible company to provide the Ministry

with any additional information as the latter may find necessary or desirable.

(3) A company conferring upon a recall in respect of a product shall immediately commence

with recall procedures and submit the following information to the Ministry:

a) Product name, pharmaceutical form and dosage,

b) batch number, date of manufacture of the product to be recalled,

c) the rationale underlying its decision for a recall and incidents where defects or potential

defects have been discovered,

ç) an assessment of the risk associated with the defect and consumer groups at risk,

d) Number of defective batches and total number of batches,

e) product quantities dispensed,

f) the names of places receiving product deliveries and quantities of product delivered at each

of them,

g) class and type of recall,

ğ) means of communication to be used in time of recall (i.e. mail etc.), a copy of the

notification thereof, if available or description on how communication will be assured,

h) names, work and home phone numbers of persons responsible for recall procedure.

(4) The Ministry shall review the information submitted to it by the responsible company and,

if it so opts, alter the class and depth of recall.

Notification

ARTICLE 71 – (1) In Class I Recalls, the Ministry will warn the public using all mass

communication means, asking them to avoid use of defective product. Within twenty-four

hours after the delivery of notification, measures shall be taken as necessary for bringing

defective products existing in the market, under control.

(2) When a decision is made for a product recall, the situation will be informed to all such

entities and people which may have in possession the product depending on the level of depth

the recall extends, via appropriate communication channels, in the shortest possible time, by

the responsible company. Regardless of the form or manner of notification, a written notice

should definitely be given. Following this notification, the products to be recalled shall be

brought under control within three days in case of Class II recalls or within six days in case of

Class III recalls.

(3) The notification of product recall made by the Company should be free of any advertising

elements and should just deliver the message to the best knowledge of the target community

groups. This notification should at least contain the following information:

a) Product name,

b) Pharmaceutical form and dosage,

c) batch number and date of manufacture,

ç) reason of recall,

d) the manner in which the product shall be recalled,

e) manner of compensation for the product recalled,

(4) The Directorate General will issue a notification through its official website on decisions

taken by it for product recalls.

Measures

ARTICLE 72 – (1) Following the notification of recall, those possessing defective products

will cease distribution and/or sales thereof. These people shall be obliged to take the

necessary measures until the recall procedure ends.

(2)(Amended:OJ-20/12/2014-29211) In case of adoption of any recall decision, then the

marketing authorization holder shall cease the manufacturing process of the product for a

period specified by the Ministry. The importation of the products manufactured abroad shall

be ceased without granting any time. The Ministry shall inform the manufacturing site and the

marketing authorization holder about its decision on continuity of the manufacturing or

importation of the product, upon submission of any information and documents in relation to

the reason of the relevant defect/failure and to any corrective and preventive measures taken

in order to prevent the re-occurrence of such defect/failure, in compliance with the good

manufacturing practices guidance.

Report arrangement

ARTICLE 73 – (1) After making sure that all defective medical products available in the

market have been retrieved, down to the level to which the recall extends, the marketing

authorization holder shall draw up and submit a report to the Ministry, which includes:

a) distribution records of defective product batch or batches (name and quantity),

b) locations, dates and manner of notification of recall,

c) number of customers observing the recall notification and quantities of medical product in

their possession,

ç) customers disregarding the warning,

d) total quantity of returning medical product (to be put on record under supervision of the

provincial / district directorate),

e) action to be taken in respect of returning medical product.

(2) The Ministry shall be informed daily about Class I recalls.

Termination of Recalls

ARTICLE 74 – (1) The Ministry will decide for terminating a product recall. The

information supplied by the responsible company shall be collated with the results of

supervisory audits conducted across the organization of the Ministry and feedback from other

sources to allow for an overall assessment of the conjuncture, at the end of which the Ministry

shall decide whether or not the recall has been completed. If the Ministry concludes that the

recall is yet at insufficient levels, it will require the responsible company to continue with it.

(2) Action proposed to be taken by the responsible company about the recalled product shall

be submitted to the Ministry for its approval. If it is approved by the Ministry, the action is

put under implementation. The Ministry is liable for giving the detailed information about the

action in progress, to the responsible company.

(3) Following Ministry’s decision for termination of the procedure of recall of products, the

information given by the responsible company shall be evaluated by the Ministry. When it

makes sure that the recall has fully been completed, the recalled products have been either

destroyed or restored and measures have been taken to prevent a recurrence of the same

defect, the Ministry will close the recall file.

Liaison

ARTICLE 75 – (1) (Amended:OJ-11/1/2013-28525)(1) Marketing authorization holders and

warehouses shall be obliged to set up a system for establishing liaison with the destinations

where deliveries of their products are made in the shortest period of time.

(2) Retail outlets have to keep records concerning medical products subject to sale on

prescription, as specified in the related Article, for tracking the recall operation.

CHAPTER EIGHT

Autovaccines

Production, distribution, use, recording and reporting of autovaccines

ARTICLE 76 – (Amended:OJ-11/1/2013-28525)(1)

(1) Manufacturing of the autovaccines shall be carried out in accordance with the below given

procedures and principles;

a) (Amended:OJ-20/12/2014-29211) Autovaccines shall be manufactured at the areas

allocated for autovaccines at the facilities, to which the manufacturing authorization has been

granted based on the veterinarian's report.

b) (Amended:OJ-20/12/2014-29211) In respect of manufacturing of autovaccines; the micro-

organism cultures, the pure culture of which is derived from the veterinary diagnosis, analysis

laboratories authorized by the Ministry, the Institute Directorates or universities, shall be

used.

c) Autovaccines may be prepared from the cultures of the micro-organisms derived from the

organs or tissue pieces of any flocks or animals at the livestock enterprise, which are infected

with disease, or which have died because of a disease, or which are suspicious of carrying

disease, and their body fluids or such other substances having a role at contagion.

ç) The flock and the animals from which the pure culture has been derived shall be identified.

Such identification shall be done by the number of that animal in respect of individually

identified ones, and by the number of the hutch in respect of the avians, and the number of the

enterprise in respect of fish and the other animals.

d) The micro-organism culture may be used for a period of fifteen months as of the date, on

which the pure culture has been derived, or within twelf months following the manufacture of

the first batch of the autovaccine in which they are used, in respect of manufacturing of

autovaccines. However, excluding flock use, the micro-organism culture may be used for a

period of twenty four months for individual use purposes, in respect of manufacturing of

autovaccines.

e) Each batch product, manufactured from the micro-organism cultures until the age of twenty

four months at the manufacturing site, and which is peculiar to the flock use, shall be

checked/controlled in terms of the quantity of residual formaldehyde if it is administered to

any animals producing food and if it is used at the manufacturing, in addition to the

control/checking of sterility, purity, inactivation. The manufacturing site may perform

additional control/checks if it deems required.

f) The manufacturing site shall obtain permission from the Ministry, by submitting the

efficiency tests for use by flocks, in respect of the autovaccines, which it manufactures by

derivation from the micro-organisms, for which a period of twenty four months has elapsed as

of the date on which it has derived the pure culture. Samples, at sufficient number, of each

batch, for which permission has been obtained, shall be retained in order for controls/checks

to be performed by the Ministry, when and if so required.

g) Labeling of the autovaccine shall bear the below listed details;

1) The name of the micro-organism from which it has been manufactured.

2) Batch number and expiry date and the volume of the package and total dosage amount.

3) Route and dose of administration, and the recommended administration frequency.

4) Conditions for storage and handling/shipment.

5) If used, the names and the quantity details of the substances used at inactivation, and any

preservative substances, adjuvants.

6) Species of the animal on which it will be administered.

7) The name and the address of the manufacturer, and the name and the address of the animal

owner or the enterprise.

8) The warning stating that the product may not be administered at the location or any other

animals other than the ones indicated on the label.

9) Name, surname and contact details of the veterinary surgeon responsible for administration

of the autovaccine.

10) The warning stating that the shelf life of the autovaccine may not exceed twelf months.

ğ) Any micro-organism culture, which could not be used at manufacturing of autovaccine or

at any other product, for which a subsequent marketing authorization may be obtained, as of

the date of creation of the pure culture, shall be disposed of by the manufacturing site; or shall

be delivered to the diagnosis or research institutions if so requested.

h) No autovaccines may be manufactured against any diseases, for which serving a

notification is mandatory as determined by basing on the law.

(2) Autovaccine may be used at the enterprises that are adjacent to or neighboring the

enterprises where the disease is diagnosed, or where the micro-organism has been isolated.

(3) In order to enable that the autovaccine can be used at the non-neighboring enterprises, the

epidemiological connections or resources such as antigenic similarity of the micro-organisms

obtained from both enterprises, existence of common hatchery or water resources between the

both enterprises, or animal and equipment shipments/transfers between the enterprises, shall

be set out.

(4) Any autovaccines peculiar to flock use may not be kept available at veterinary

pharmaceutical warehouses, animal hospitals, veterinary surgeon clinics or polyclinics.

(5) Autovaccines peculiar to individual use may be kept available at animal hospitals,

veterinary surgeon clinics and polyclinics. However, the label of the autovaccine shall contain

the details about the animals, for which the autovaccine has been prepared, in addition to the

other details indicated on the label.

(6) Any livestock enterprises, which employ veterinary surgeons within their organization for

animal health-care services, may keep the autovaccine within their organization. The

manufacturing site shall deliver the autovaccine to such kind of enterprises at a quantity

sufficient for primary and repeated vaccination of the flock for which the autovaccine will be

administered. Any products, which will remain after the vaccination, shall be returned to the

manufacturer.

(7) The responsibility in respect of storage and administration of autovaccines at the the

livestock enterprises, which do not employ veterinary surgeons within their organizations,

shall be incumbent on the manufacturing site and the owner of the enterprise. Administration

may be performed by the veterinary surgeon or the assistant health-care personnel, working

within the organization of the location where the autovaccine is manufactured, or by the

veterinary surgeon clinic or the animal hospital which will be mutually determined by the

manufacturing site and the livestock enterprise.

(8) The livestock enterprise shall be obliged to keep and retain the details in relation to the

storage temperature and administration records, the invoice, and the return documents, if any,

of the autovaccine, which it has received, on regular basis.

(9) The manufacturing site shall keep and retain the details about the micro-organism culture

and isolation details of the autovaccine, and the manufacturing and control records, the

invoices and delivery forms of the same, the dates and quantities of the delivery, the details

about the person to administer, and the addresses of the enterprise and the person to

administer, and the records regarding the other contact details.

(10) Manufacturing of autovaccine only for exportation purposes shall be carried out in

accordance with the below given procedures and principles:

a) Exportation may be carried out in the form of finished product or bulk product.

b) In order for importing the pure micro-organism to be used for manufacturing of

autovaccines for exportation purposes, the authorization of the Directorate General shall be

obtained. No ill or dead animals, organs or tissue pieces or body fluids may be imported for

such purposes.

c) The application for obtaining authorization for the micro-organism culture shall contain the

details about the isolation and identification, and the request of the buyer.

ç) The labeling/labels of the products, to be manufactured for exportation purposes, shall be

drawn up and prepared in the language as requested by the country to which such products

will be exported. Such labeling/label shall contain the warning "Manufactured for use by/in

.................", and the name of the country only, in Turkish, to which such products will be

exported.

(11) Autovaccine manufacturing of any manufacturing site, which do not comply with, and

adhere to the procedures and guidelines specified in this Article, shall be ceased for a period

of one year.

(12) (Insertion:OJ-20/12/2014-29211) Any other matters in relation to the production,

protection and use of autovaccines shall be determined in accordance with the guidance to be

published by the Ministry.

CHAPTER NINE

Audits, Penalties, Suspension and Revocation Procedures

Suspension of the marketing authorizations of the products and the activities of the

competent pharmacovigilance service institution

ARTICLE 77 – (Amended along with the heading:OJ-20/12/2014-29211)

(1) Marketing authorizations for all products possessed by an authorization holder shall

collectively be suspended, when it is clear that:

a) The operating license or authorization is suspended,

b) The mail delivery address of the marketing authorization holder cannot be determined,

c) the information and documents submitted for operating license application prove to be

false, forged or counterfeited.

(2) Marketing authorizations shall be suspended in case of any of the following cases:

a) if it is detected that the product proves to be ineffective or unsafe under the recommended

conditions of use,

b) the product proves to be harmful under the recommended conditions of use,

c) if the product is not manufactured in compliance with the manufacturing method,

pharmaceutical form, leaflet, labeling and presentation form, or if it is not released to market

accordingly,

ç) the product has been placed on the market without any sales authorization,

d) there is no antigenic coherence between strains contained in the veterinary biological

product and the pathogenic strains found in Turkey,

e) if it is detected that the information and documents submitted to the Ministry regarding the

product prove to be false, forged or counterfeited.

f) if it is detected that the marketing authorization holder manufactures the product, has the

product manufactured, or releases the product to the market, by failing to comply with the

regulations,

g) Quality control testing for each manufactured batch, in combination with production and

control tests concerning the by- and intermediate products occurring during the production

process for the veterinary medical product or constituents thereof prove to be inconsistent

with the defined methods,

ğ) if it is detected that the manufacturing and quality control testing methodologies of the

products are not updated in accordance with recent scientific progress,

h) if the pharmacovigilance activities regarding the product are not being performed, or if it is

continued to perform insufficient and lacking activities in spite of the warning thereto,

i) if the authorization holder does not inform the Ministry on all incidental developments of

the product authorized abroad,

i) if any information or documents is/are not sent to the Ministry within the granted period of

time,

(3) The manufacturing or importation of a product, the authorization granted for which has

been suspended, will immediately be ceased. Decision concerning the products, which are not

placed on the market, and which are being distributed or on sale, will be taken by the

Ministry, having due regard to the grounds of suspension.

(4) In the event that it is detected that the product is not in compliance with the formula and

specifications that constitute the basis for the marketing authorization of such product, upon

the analysis performed on any products having sales authorization by the Ministry, then

actions as per the sub-paragraph (d) of the first paragraph of Section 37 of the Law shall be

taken.

(5) After the authorization is suspended, the Ministry will cancel the suspension, if it agrees to

the counter-arguments put up in documents, information and reasoning revealed by the

authorization holder in his objection after receipt of the notification of suspension from the

Ministry.

(6) The activities of the competent pharmacovigilance service institutions shall be suspended

if;

a) The certificate of authorization is suspended,

b) The mail address of the competent pharmacovigilance service institution cannot be

identified,

c) The information and documents submitted for certificate of authorization are proved to be

false, forged or counterfeited,

ç) The fact that the Ministry is not informed about the termination of the pharmacovigilance

service agreement within the granted period of time is repeated,

d) The competent pharmacovigilance manager resigns from office and it is detected that a

new manager is not assigned within the granted period of time,

e) It is detected as a consequence of the audits that no responsibilities are carried out.

Revocation of marketing authorizations for the products

ARTICLE 78 –(Amended:OJ-20/12/2014-29211)

(1) Marketing authorizations for the products will be suspended if;

a) the authorization holder so requests;

b) the products are found to bring no benefit when used as intended and are unnecessary for

the practice or domain of veterinary medicine for which they are meant for use or are widely

used for purposes other than intended;

c) the authorization holder does not submit any information and documents in relation to the

grounds of suspension, to the Ministry within a period of six months as of the date of

suspension, at the latest, and does not take and initiate any required measures for grounds of

suspension, or does not carry out the relevant processes, or if such information, documents,

measures and processes are not deemed appropriate by the Ministry; in respect of the

products, authorization of which has been suspended; excluding the provisions of the sixth

paragraph of the article 65 of this Regulation,

ç) the assessment is performed based on the matters such as the reason of the cancellation and

authorization status of the product in other countries, in case of cancellation of the

authorization of the products, which are authorized abroad, in the country, where they are

authorized.

(2) The manufacturing or importation of a product, the authorization granted for which has

been canceled, will immediately be ceased. Decision concerning the products being

distributed or on sale will be taken by the Ministry, having due regard to the grounds of

revocation.

(3) The Directorate General will issue a notice to the persons and the related parties involved

in the trades of the products, the authorization of which has been revoked, with justification of

the reasons entailing to such revocation.

Supervision of manufacturing sites, and sanctions

ARTICLE 79 – (1) The Ministry shall inspect the premises, for which a manufacturing

authorization has been obtained, by informing the same in accordance with a schedule for

such purpose, and also without informing the same, at any time when it may deem required.

The specialists of the Ministry are authorized to examine any and all kinds of manufacturing,

quality control, quality assurance documents and such other records, and to take any samples,

when and if they deem required, as per the purpose of such inspections. Upon completion of

inspections, the authorized representatives will draw up a report which ascertains whether or

not the manufacturing site complies with legal requirements stipulated under this Regulation,

or not. The report will specify the matters which should be reported to the manufacturer who

has undergone an inspection and the Ministry will notify these matters in writing to the

manufacturer.

(2) As a result of the inspections carried out, if it becomes obvious that the authorization

holder is in breach or violation of the provisions of this Regulation, the Ministry may suspend

until such time when non-conformities are removed for certain pharmaceutical forms or

completely withdraw the manufacturing authorizations.

(3) The Ministry may further suspend or withdraw the powers of responsible persons of the

manufacturing sites found to be operated in violation of the provisions of this Regulation.

(4) Should the powers of the responsible person are revoked, a replacement shall immediately

be elected and appointed to this position. In case of suspension of powers of the responsible

person, a new replacement should immediately be selected and appointed to hold office also

for the duration in which the suspension will stand.

Supervision of sales points and sanctions

ARTICLE 80 – (1) Veterinary pharmaceutical warehouses shall be inspected at least twice,

and retail outlets shall be inspected at least once in every year. Other than that, inspections

may be carried out, when they are considered necessary. Such inspections shall be carried out

by authorized representatives of the provincial directorate in cooperation with personnel of

the relevant departments of the Directorate General. If the physical location of the sales points

falls within districts, the authorized personnel of the related district directorates will also join

the team to carry out inspections.

(2) Inspections shall check and verify whether the wholesalers and/or retail outlets being

visited pursue operations in accordance with the applicable laws and information as stated in

the filing for operating license/authorization applications, whether the responsible person

named in such license or authorization physically attends his office and whether the records

are kept regularly and in order. Points discovered as not in compliance with the applicable

laws during inspections shall be put on record in the inspection logbook and then duly signed

by the responsible person named in the license/authorization.

(3) Action shall be taken with regard to points thus ascertained, as follows:

a) If the point that needs attention involves no risks or threat to safety of the product, then it

should be eliminated or made good in a period of fifteen days. If, at the end of such period,

non-conformities are found to persist, then activities of warehouses shall totally be ceased and

their licenses suspended. In the case of retail outlets, the licenses/authorizations shall be

suspended and they are prevented from any further sales of the veterinary medical products,

which will be entrusted to an appointed trustee, to keep them in safe custody. If the non-

conformities are either eliminated or made good, then necessary set of examinations shall be

made and those retail outlets which are found to comply with all applicable law provisions

shall be permitted to continue with their operations. However, those retail outlets failing to

fulfill their obligations despite a period of two months has passed from the date of inspection

shall witness their licenses/ authorizations totally withdrawn.

b) If the point that needs attention involves risks or threat to safety of medical product for

veterinary use, then a time allowance of one month at first-time inspections or of six months

at secondary inspections or of one year at tertiary and subsequent inspections shall be granted

for the elimination of non-conformities. If, at the end of such period, non-conformities are

found to have been eliminated or made good after necessary set of inspections have been

performed then activities of retail outlets shall totally be authorized or in the case to the

contrary, totally revoked.

c) (Amended:OJ-11/1/2013-28525)(1) Those retail outlets found to have been engaged in

sales of veterinary medical products off the record and under the counter or without a validly

obtained marketing authorization will receive application of sanctions mentioned in point (b),

first paragraph of Section 37 of the Law.

ç) Those veterinary pharmaceutical warehouses and retail outlets conducting sales of

veterinary medical products without a wholesale or retail distribution authorization will

receive sanctions and penalties delineated in point (g), first paragraph of Section 37 of the

Law.

d) Those retail outlets which have demonstrably failed to keep such records as required by the

Ministry in relation to medical products for veterinary use will receive application of

sanctions mentioned in point (i), first paragraph of Section 37 of the Law.

e) Those retail outlets which retain or hold in possession or market and sell medical products

for veterinary use in torn or ripped or otherwise opened packaging or decomposed or outdated

veterinary medical products shall receive application of sanctions mentioned in point (j), first

paragraph of Section 37 of the Law.

f) Those who have demonstrably failed to comply with the requirements of third, fifth,

seventh, eighth and ninth paragraphs of Article 34 of this Regulation in relation to medical

products for veterinary use will receive application of sanctions mentioned in point (i), first

paragraph of Section 37 of the Law.

g) (Insertion:OJ-11/1/2013-28525)(1) Any persons, who fail to notify any changes regarding

the service conveyance vehicles or their equipment during obtaining retail sales

authorizations, shall be warned upon the first detection of such case. Upon any subsequent

detections or if it is detected that the products are handled/shipped in an inappropriate manner

to affect the quality and reliability of the products, then the actions specified in sub-paragraph

(b) of this paragraph shall be taken.

ğ) (Insertion:OJ-11/1/2013-28525)(1) Any products, which are detected to have been stored

at inappropriate conditions or shipped at veterinary pharmaceutical warehouses, retail outlets

or inside any means of conveyance vehicles belonging to the same, and the records for storage

or shipment temperatures of which have been detected to have not kept, or kept missing, shall

be given to a trustee, and such products shall be had analyzed. Any products, which are

detected to be inappropriate/non-conforming upon such analysis, or which are not allowed to

be checked/controlled by their owners, shall be sequestrated, and the title to such products

shall pass to the public in order to be disposed of. Any costs and expenses for shipment,

analysis and disposal of such products shall be borne by the owners of the same.

(4) (Insertion:OJ-11/1/2013-28525)(1) Any persons, who fail to keep the records specifed in

the seventh paragraph of Article 48, shall be subjected to penal sanctions specified in the sub-

paragraph (ç) of the first paragraph of Section 36 of the Law.

Revocation of warehouse license or retail sales authorization

ARTICLE 81 – (1) Warehouse licenses or retail sales authorizations will be revoked or

withdrawn, if:-;

a) requested;

b) the information and documents submitted in support of the application prove to be false,

forged or counterfeited;

c) (Abrogated:OJ-11/1/2013-28525)(1)

ç) the license or authorization for clinics, polyclinics or hospitals have been revoked;

d) the responsible person is prevented to carry out his profession or banned from professional

conduct for at least a period of three months or he dies,

e) the operations of the retail outlet is suspended for enforcement of financial and commercial

laws;

f) the article governing inspections and sanctions so requires.

(2) The documents and records as well as licenses or authorizations belonging to a warehouse

or retail outlet, the operating license or retail sales authorization of which has been withdrawn

for any reason whatsoever shall be lodged to the provincial directorate. These documents and

records will be kept in safe custody for as long as required by this Regulation, at the

provincial directorate. The aforesaid will subsequently be returned or transferred to the

manufacturer or legitimate owner or of the wholesaler or retail outlet found in the location of

sales of the products. If any transfer or return procedure has been scheduled at a later date, the

products shall be brought under control and provisional custody of a trustee. The transfer and

return procedures of narcotic and psychotropic products will be conducted in presence and

under supervision of authorized representatives of the provincial directorate.

Promotion

ARTICLE 82 – (1) The Ministry shall inspect all kinds of materials and methods employed

in promotional activities, as well as the promotional activities themselves, either when it

deems necessary or based on a filed complaint. The Ministry shall require from the

license/authorization holders that any promotional activities found inconsistent with the

principles set forth in this Regulation or ineligible for public health be ceased or terminated or

the information supplied through the promotional materials be revised or withdrawn,

depending on the case. Such requests of the Ministry as aforementioned will immediately be

fulfilled.

(2) Those who fail to comply with rules and principles applicable to promotional activities

shall, pursuant to point (h), first paragraph Section 37 of the Law and depending on the nature

and character of their actions, receive treatment in accordance with the relevant provisions of

Turkish Penal Code, Law No. 5237 of 26/9/2004, Consumer Protection Law No: 4077 of

23/2/1995, 4054 Numbered Law of 7/12/1994 on the Protection of Competition and 6112

Numbered Law of 15/2/2011 on Radio and Television Enterprises and Broadcast Services.

(3) (Amended:OJ-11/1/2013-28525)(1) The Ministry shall, in addition to imposing the

sanctions applicable to cases where the products are promoted in such a way contrary to the

provisions of this Regulation, warn the authorization holder. If the same misconduct recurs

despite such warning as aforementioned, the product authorization shall be suspended for six

months at the first time and for twelve months at the second time and finally be revoked at the

third time.

(4) The Ministry may publish or require, from the authorization holders, to publish a

corrective statement through mass communication means in respect of a promotional activity

or material or communication containing erroneous or misleading information, which might

lead to undesirable consequences, should it so opts or deems necessary.

(5) If matters connected to promotional activities and materials occur through activities

specified in Article 55 of this Regulation, then the authorization holder shall receive an

official warning, in addition to the sanction imposed. If the same misconduct recurs despite

such warning as aforementioned, the product authorization shall be suspended for six months

at the first time and for twelve months at the second time, by such means as specified in

Article 55 of this Regulation. If the misconduct occurs for a second time, then authorizations

will be suspended for a period of twelve months.

(6) (Insertion:OJ-20/12/2014-29211) No promotion may be performed inconsistently with

the instruction and guidance of the Ministry. Any promotions performed in such a manner

shall be considered as inappropriate promotions, and the provisions of the subparagraph (h) of

the first paragraph of the article 37 of the Law shall be applicable.

Pharmacovigilance

ARTICLE 83 – (1) The Ministry will require due remedial action from the

license/authorization holder all within three months, should it finds out that there is not a

system for monitoring pharmacovigilance activities in place and running, no person has been

appointed to assume responsibility for pharmacovigilance and there are non-conformities with

or violations of this Regulation, upon conducting the necessary reviews and inspections. At

the end of the above mentioned period, should the non-conformities or violations still persist,

the sales authorizations of the defaulting holders shall be suspended.

(2)(Insertion:OJ-20/12/2014-29211) In the event that it is detected, during the audit carried

out by the Ministry at the competent pharmacovigilance service institution, that

pharmacovigilance studies, assumed on behalf of the marketing authorization holder, are not

carried out, or in case of detection of any non-conformity or violation in the Regulation, then

the deficiency, non-conformity or violation detected shall be requested to be eliminated within

a period of three months. In case of any failure in elimination of deficiencies, non-

conformities or violations, then the sales authorizations of the holders, who have not

eliminated such matters, shall be suspended.

CHAPTER TEN

Miscellaneous and Final Provisions

Lost licenses and authorizations

ARTICLE 84 – (Amended:OJ-11/1/2013-28525)(1)

(1) In case of loss of any product marketing authorization, warehouse license, retail sales

authorization, the license or authorization holders shall apply to the competent authority from

which they have obtained their licenses or authorizations originally, along with a petition and

the receipt, proving that the relevant charge and fee have been fully paid, and also by adding

the distorted form of such license or authorization, if the same has been distorted illegibly.

The relevant authority shall re-issue such license or authorization.

Objections

ARTICLE 85 – (1) Objections to be raised against official supervisions and inspections

conducted by the Ministry will be made according to Section 31 of the Law. Objections

against testing and analyses of the products will require repetition thereof at laboratory

facilities designated by the Ministry, the resultant findings of which to be final and binding.

Repealed regulation

ARTICLE 86 – (1) Regulation on Licensing of Veterinary Pharmaceutical and Medical

Preparations and Products enacted on publication in the Official Journal No: 24915 of

23/10/2002 is hereby repealed.

(2) Regulation on Private Veterinary Laboratories, enacted on publication in the Official

Journal No: 23821 of 19/9/1999 is hereby repealed.

Guidance and guidelines

ARTICLE 87 – (1) The guidance and guidelines on pharmacovigilance and manufacturing

sites, which have been incorporated into the context of this Regulation by reference, shall be

prepared by the Directorate General, and published through the official website of the

Ministry, within twelve months following publication of this Regulation, while other

guidance and guidelines shall be prepared and published within a period of three months from

the same date.

(2) (Insertion:OJ-20/12/2014-29211) In the event that there is not any provision in relation to

the matters such as development, authorization and manufacturing of the products in the

guidance materials published by the Ministry, then the guidance materials of the institutions

and organizations such as the European Union, World Health Organization, International

Pharmaceutical Inspection Convention (PIC), International Cooperation on Harmonisation of

Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and

International Cooperation on Harmonisation (ICH), respectively, shall be taken into account.

Transitional Provision

PROVISIONAL ARTICLE 1 – (1) (Amended:OJ-11/1/2013-28525)(1) By the date of

effect of this Regulation, the licenses or authorizations previously granted for the products

having not been placed on the market, or having not been exported for the last three years will

be considered as revoked, should they are not placed on the market or exported within a

period of eighteen months as of the date of effect of this Regulation.

(2) The authorizations granted to the products, for which no application has been filed for

time extension, up until the date of effect of this Regulation pursuant to Section 34 of the

Regulation on Licensing of Veterinary Pharmaceutical and Medical Preparations and Products

enacted on publication in the Official Journal No: 24915 of 23/10/2002 shall be deemed as

null and void.

(3) Consideration as to which authorizations for the products that meet the requirements of the

thirteenth paragraph of Article 5 of this Regulation should be revoked shall be made by the

Ministry having due regard to the opinion of the international proprietor concerning

empowerment and the agreements between licensees of the products. The time for

consideration shall be two years starting as of the date of effect of this Regulation.

(4) Holders of licenses, preliminary authorizations or applicants of any domestic or imported

products shall be obliged to submit to the Directorate General within three years following the

date of effect of this Regulation, the documents proving that the sites at which the products

have been manufactured comply with the requirements of this Regulation. Otherwise

authorizations of the products shall be suspended until such time when the documents

required are submitted or the site is replaced with another, approved alternative.

(5) The license or authorization holders will apply to the Directorate General for obtaining

operating licenses within six months following the date of effect of this Regulation, or for

obtaining quality management system certificates, which are essential for operating licenses,

within eighteen months following the same date. The operations, falling within the scope of

coverage of this Regulation, of those license or authorization holders not having applied for

an operating license and presented a quality management system within the granted periods of

time shall be ceased.

(6) The license or authorization holders must have at their disposal a person responsible for

pharmacovigilance, duly appointed according to the relevant article of this Regulation, within

three months following the date of effect of this Regulation. Non-applying license or

authorization holders will not be permitted to place their products on the market.

(7) (Amended:OJ-20/12/2014-29211) The owners of the products in respect of which

formalities were started or concluded for manufacturing authorizations or preliminary

authorizations for imports to be issued, or products that are already licensed by the Ministry,

before the date of entry into force of this Regulation, should adapt their files to the

requirements of this Regulation, and then resubmit them to the Ministry within a period of

two years in addition to the period granted for adaptation of the good manufacturing practices

specified under the eighth paragraph of this article, and provided that the manufacturing site

complies with the fourth paragraph of this article. The licenses, manufacture or importation

preliminary authorizations of those who fail to submit the file to the Ministry within the

mentioned period shall be revoked. In respect of the files in relation to the products, which are

found out to be considerably insufficient in accordance with the provisions of this Regulation

in technical and administrative terms, the owners of such files, who have applied within the

granted period of time, shall be informed, and shall be granted with a further period of

maximum one year by the Ministry as of the date of notification, starting from the end of the

period of two years specified above, at the earliest. Such products may not be manufactured or

imported within a period of one year. The licenses or authorizations granted to the products,

the files of which have not been harmonized with the requirements of this Regulation, for

resubmission in due time shall be revoked.

(8) (Amended:OJ-20/12/2014-29211) The periods granted to the veterinary medical product

manufacturing sites authorized by the Ministry in order to enable them to obtain the good

manufacturing practice (GMP) certificate, and any other matters in relation thereto are

provided as follows. The activities of the manufacturing sites, which have not obtained the

certificate until the dates specified below, shall be terminated, and the operating and

manufacturing authorizations granted by the Ministry shall be deemed to have been canceled.

a) The manufacturing sites of the Foot and Mouth Disease, Brusella, Sheep and Goat Plague,

Sheep and Goat Pox, Anthrax and Blue Tongue vaccines and Tuberculin and Mallein tests

shall be obliged to obtain good manufacturing practices (GMP) certificate until 24/12/2019 in

order for manufacture of such products. In the event that such facilities manufacture any

different products, then the marketing authorizations of the respective products and all

authorizations granted by the Minister for the manufacturing sites shall be canceled, and the

relevant provisions of the article 37 of the Law shall be applicable to the facility and its

owner.

b) In respect of the veterinary medical products to be exported, the manufacturing sites, where

such products are manufactured, shall be obliged to obtain good manufacturing practices

(GMP) certificate until 31/12/2015, provided that the authorization is obtained from the

Ministry, and that the products, for which authorization is obtained, are not placed on the

market in Turkey, and that only such products are manufactured at the manufacturing sites

authorized. In the event that it is acted in breach of such provisions, then the marketing

authorizations of the respective products and the manufacturing site authorizations shall be

canceled, and the relevant provisions of the article 37 of the Law shall be applicable to the

facility and its owner.

c) The manufacturing sites and facilities, where any products other than those specified under

the subparagraphs (a) and (b) of this paragraph, shall be obliged to obtain good manufacturing

practices (GMP) certificate until 31/10/2015. The authorizations of the facilities, which have

failed to obtain their certificates, shall be deemed to have been canceled.

(9) (Amended:RG-11/1/2013-28525)(1) Any sales points, having previously been granted

with retail sales authorizations for veterinary medical products by the Ministry, shall be

obliged to obtain a veterinary medical product retail sales authorization in accordance with the

provisions of this Regulation until 15/10/2013. Otherwise their current sales authorizations

shall be revoked.

(10) All pharmaceutical warehouses selling veterinary medical products, including those

licensed by the Ministry of Heath, and veterinary pharmaceutical warehouses storing

veterinary biological products must apply to the provincial directorate to obtain a veterinary

pharmaceutical warehouse license within one year following the date of entry into force of

this Regulation. Those pharmaceutical warehouses, which fail to make the application as

aforementioned, will not be permitted to enter into trade dealings of veterinary medical

products; and their previously given biological product warehouse licenses will be deemed

null and void.

(11) (Amended:OJ-20/12/2014-29211) The operating authorizations, granted to the

manufacturing sites of the Foot and Mouth Disease, Brusella, Sheep and Goat Plague, Sheep

and Goat Pox, Anthrax and Blue Tongue vaccines and Tuberculin and Mallein tests for the

purpose of manufacture of such products, shall be accepted by the Ministry until 24/12/2019;

and the manufacturing and operating authorizations granted to the manufacturing sites, where

veterinary medical products to be exported are manufactured, shall be accepted by the

Ministry until 31/12/2015; and the manufacturing and operating authorizations, granted to the

manufacturing sites of any other products, shall be accepted by the Ministry until 31/10/2015.

(12) Any promotional items not complying with the provisions of this Regulation should be

removed from use in no later than six moths following the date of entry into force of this

Regulation. In this case, the marketing authorization holder will ultimately be held liable for

any misinformation in promotional materials.

(13) The charge-free sample dispensing period mentioned in the fourth paragraph of Article

53 hereof will be one year as of the date of entry into force of this Regulation, for all products

granted with a license or authorization at any time before enactment of this Regulation.

(14) (Insertion:OJ-20/12/2014-29211) The veterinary pharmaceutical warehouses licensed

shall be obliged to carry out the requirement for determination of the scope of the activity

specified under the first paragraph of the article 36 of this Regulation, and the requirement

specified under the twelfth paragraph of the article 39 of this Regulation, within a period of

one year following the announcement of the products and quantities thereof, required to be

kept available, by the Ministry, and shall be obliged to obtain their licenses for the scope of

the activity. The activities of the warehouses, which fail to obtain their licenses, shall be

suspended.

(15) (Insertion:OJ-20/12/2014-29211) The marketing authorization shall be issued by the

Ministry for the veterinary biological products, for which preliminary authorizations for

imports or the manufacturing authorization is granted by the Ministry. Such products shall be

exempted from any renewal processes specified under the second paragraph of the article 65

of this Regulation until issuance of a new marketing authorization.

Effect

ARTICLE 88 – (1) This Regulation shall come into effect on the date of its promulgation.

Enforcement

ARTICLE 89 – (1) The provisions of this Regulation shall be enforced by the Ministry of

Food, Agriculture and Livestock.

_______

(1) This amendment shall come into effect on the date of its promulgation, to be effective as of

24/12/2012.

(2) By means of Article 29 of the amendment regulation, issued on the Official Journal, dated

11/1/2013, numbered 28525, the fourth paragraph has been added so as to follow the third

paragraph of this Article, and the following paragraph has been continued accordingly.

Details on the Official Journal on which the Regulation has been promulgated

Date Number

24/12/2011 28152

Details on the Official Journals on which the Regulations Amending this

Regulation have been promulgated

Date Number

1. 4/4/2012 28254

2. 11/1/2013 28525

3. 20/12/2014 29211